Associate Director, Quality Assurance Resume Samples

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A Lindgren

Alicia

Lindgren

91615 Kovacek Prairie

New York

+1 (555) 704 1593

91615 Kovacek Prairie

New York

Phone

p +1 (555) 704 1593

Experience Experience

Houston, TX

Associate Director Quality Assurance

Houston, TX

Harber-Brekke

Houston, TX

Associate Director Quality Assurance

Create and oversee process to conduct audits and provides feedback to reduce defects and improve processes and performance
Support Annual Product Quality Reviews (PQR) for assigned projects by consolidation/ summarization of internal and contractor data. Assure timely completion and communication in alignment with procedures and Quality Agreements
Develop new workplace audits of processes to flag issues prior to having a member impact
Coordinate, prepare, and manage CMC (Quality) documentation for submissions and subsequent variations/supplements. This includes both post-market changes and routine annual updates
Work to understand processes, identify failure points, and develop quality assurance/audit programs to ensure operational excellence is achieved
Provide technical support to investigations
Manage Life Cycle for products, including coordinating quality related activities

Boston, MA

Associate Director, Quality Assurance

Boston, MA

Jones, Connelly and Macejkovic

Boston, MA

Associate Director, Quality Assurance

Leads continuous improvement efforts in quality systems and department infrastructure through the evaluation of trends in key performance indicators, audit feedback, and corrective and preventative actions
Represent QA in site management teams and continuous improvement initiatives. Ensures the evaluation, trending, and communication of quality data and information for management review
Develops plans and implements actions to ensure that the site operates in conformity with Gilead, CGMP and Chinese FDA expectations. Ensures site readiness for regulatory and audit inspections
Oversees the performance of all deviation investigations; ensures robust corrective actions are identified and implemented. Chairs Material Review Board meetings
Establishes and maintains systems for the quality oversight of outsourced operations (e.g. contract manufacturers, contract suppliers, contract laboratories) which provide APIs, raw materials to the manufacturing site
Directs QA support for the review and approval of batch record, validation, specification and change control documentation
Provides support for the oversight of site validation activities

present

Dallas, TX

Associate Director Quality Assurance GLP

Dallas, TX

Wilkinson-Moore

present

Dallas, TX

Associate Director Quality Assurance GLP

present

Manage staff including assignment of the workload
Assist in the development or revision of GLP QA standard operating procedures
Assist in the development of compliance programs
Prepare written reports for each study audit/inspection and submit to Principal Investigator, management, Study Director and other relevant personnel
Perform final report and data audits to assure the report accurately reflects the raw data and all methods and procedures specified in the protocol and SOPs
Provide GLP training
Fulfill QA roles as assigned in TrackWise

Education Education

Bachelor’s Degree in Biological Sciences

Clark Atlanta University

Bachelor’s Degree in Biological Sciences

Skills Skills

Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment
Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment
Considerable knowledge of quality assurance processes and procedures
Strong knowledge of pharmaceutical research and development processes and regulatory environments
Ability to work in a dynamic, fast paced environment and maintain professional demeanor
Experience in recruiting and maintaining skilled QA talent is highly desirable
Monitors efforts to improve the EP’s quality and reliability through ongoing oversight and formal communication programs and forums
Quality Control, Quality Assurance and/or Regulatory Compliance experience
Solid knowledge in FDA regulations, especially the cGMP for the 21st century initiatives as well as global GMP
Executes a program of calibrated Quality oversight based on the product type, capabilities, and quality and compliance performance of the EP

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Associate Director, Quality Assurance Resume Examples & Samples

Ensures that a compliant Quality Management System is established and maintained in conformity with applicable company and US/worldwide regulatory requirements, standards, guidance and procedures
Leads continuous improvement efforts in quality systems and department infrastructure through the evaluation of trends in key performance indicators, audit feedback, and corrective and preventative actions
Represent QA in site management teams and continuous improvement initiatives. Ensures the evaluation, trending, and communication of quality data and information for management review
Provides CGMP guidance to internal departments for all phases of product development, as applicable. Ensures efficient and effective QA support for solid dosage form drug product manufacturing
Develops plans and implements actions to ensure that the site operates in conformity with Gilead, CGMP and Chinese FDA expectations. Ensures site readiness for regulatory and audit inspections
Oversees the performance of all deviation investigations; ensures robust corrective actions are identified and implemented. Chairs Material Review Board meetings
Establishes and maintains systems for the quality oversight of outsourced operations (e.g. contract manufacturers, contract suppliers, contract laboratories) which provide APIs, raw materials to the manufacturing site
Ability to travel up to 15% of the time for face to face visits
Directs QA support for the review and approval of batch record, validation, specification and change control documentation
Provides support for the oversight of site validation activities
Responsible for hiring, mentoring and performance management of QA staff members
Develops and maintains budgets and hiring plans
Strong working knowledge of CGMP and Chinese FDA concepts/requirements as it applies to the quality arena in small molecule Drug Product manufacturing
Proven track record in strategic planning for the start-up of a Drug Product manufacturing and packaging site
Demonstrates ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors
Experience overseeing QC laboratories is desirable
Experience in recruiting and maintaining skilled QA talent is highly desirable
Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment
Manages QA personnel, including organizing and prioritizing group tasks, performing training, writing performance reviews and guiding personnel in longer-term development
Performs a wide variety of activities to ensure compliance applicable regulatory requirements, to facilitate compliance with regulatory agencies, customer and MA holder requirements
Develops, implements, and maintains systems, programs and processes to ensure compliance with Current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs), along with compliance of protocols, GMPs and safety regulations
Responsibilities may include the approval of processes affecting all manufactured products into Europe and other countries
Creates, implements, and qualifies current and new programs, policies, processes, procedures and controls to ensure that performance and quality of products conform to established standards and agency guidelines
Reviews and approves training programs regarding implementation of quality systems
Interfaces with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorate bodies as required
10+ years of relevant experience in the pharmaceutical industry and a BS or BA
Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment
Demonstrates in-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally
Demonstrates substantial knowledge of industry best practices and trends
Is comfortable interacting with regulatory agencies as needed and possess the ability to represent Gilead in public forums
Demonstrates excellent verbal, written, and interpersonal communication skills

Associate Director, Quality Assurance Resume Examples & Samples

Assist in Developing Staff
Provide leadership and mentorship to junior staff to build robust and aligned capabilities within the department
Identify gaps in training and assist in creating development goals for the group
Lead by example and maintain professional demeanor and collaboration throughout interactions with colleagues
Demonstrates effective ability to mentor and lead junior staff
Ability to allocate time and resource appropriately and nimbly to meet changing priority requirements
Ability to work in a dynamic, fast paced environment and maintain professional demeanor
10+ years of QA experience supporting clinical operations
Demonstrates expert knowledge of global quality and compliance requirements for clinical products
Demonstrates ability to manage/support multiple complex projects at the same time

Associate Director, Quality Assurance Resume Examples & Samples

Overseeing GMP quality and compliance activities across Ironwood and its Vendors. Set and meet objectives and expectations for quality systems of CMOs and other vendors
Review and approve master and executed production records
Prepare disposition statements of clinical and commercial materials based upon the review of all pertinent records, CoC, and CoA for the approval and distribution of GMP materials
Develops GMP audit plans and conducts and/or manages compliance audits of contract research organizations, CMO manufacturing operations, suppliers and other service providers. Tracks audit response and respective CAPA closure for audit findings
Provides support for all regulatory inspections, at Ironwood and it’s CMOs
Contributes to the periodic reports for management review on the status of compliance, and quality standards of all facilities, processes, procedures and practices. This may be in the form of an evaluation of Quality metrics, the preparation of technical reports, and the communication of key findings
10 years of experience in Quality and Compliance management in pharmaceutical industry
Excellent understanding of Good Manufacturing Practices
Demonstrated ability to think strategically and to be able to outline and drive successful implementation
Understanding of clinical development from Phase 1 to Phase 3 would be an important advantage
Strong knowledge and experience with ICH, USP, 21CFR210, and 21CFR211
Experience conducting contract manufacturing site assessments and cGMP audits
Experienced in preparing and negotiating quality agreements with CMOs
Ability to work independently and collaboratively within project teams to attain team goals
Demonstrate strong organizational and interpersonal skills, building relationships with effective communication, influencing, conflict resolution, critical thinking and problem solving with a keen attention to detail

Associate Director Quality Assurance GLP Resume Examples & Samples

Have expert knowledge of FDA and OECD Good Laboratory Practice regulations and requirements, and FDA 21 CFR Part 11 regulations
Inspect critical phases of ongoing studies for compliance with the study protocol, GLPs and SOPs
Conduct internal facility inspections of laboratory equipment, personnel, methods, computer systems, facilties and records
Perform final report and data audits to assure the report accurately reflects the raw data and all methods and procedures specified in the protocol and SOPs
Evaluate protocols for compliance with GLPs and SOPs
Prepare written reports for each study audit/inspection and submit to Principal Investigator, management, Study Director and other relevant personnel
Review and approve standard operating procedures related to GLP site activities for compliance with regulations, good documentation practices and compatability to related SOPs
Perform inspections of contract research organizations (CROs) used for toxicology studies and preclinical and clinical bioanalysis for compliance with FDA and OECD GLP regulations, and relevant guidelines
Fulfill QA roles as assigned in TrackWise
Provide GLP training
Assist in the development of compliance programs
Assist in the development or revision of GLP QA standard operating procedures
Manage staff including assignment of the workload
Maintain audit inspection logs including tracking of audit responses
Serve in an advisory capacity as a subject matter expert to departments that support GLP studies
Interact with regulatory inspectors during GLP inspections of Teva facility
Maintain knowledge of regulatory agencies’ change in regulations/guidelines, current trends, and areas of focus

Associate Director, Quality Assurance Resume Examples & Samples

Creates a clear and unifying vision for the quality assurance area to assure product and process compliance. Fosters enthusiasm, commitment and dedication to the unifying vision within the team
Define and champion implementation of compliance strategies, quality plans and Commercial Quality Assurance programs for the management of Takeda outsourced material procurement, product manufacturing/packaging operations and label quality to assure the quality and compliance of TPUSA and and external supplycommercial products
Independently and directly represent Takeda to make decisions on acceptability of Third Party Manufacturers’ and Packagers’’ quality programs and ongoing activities
Oversee the Quality Label program and processes, to ensure compliance with current Good Manufacturing Practice (cGMP) regulations and TPUSA quality expectations
Establish TPUSA QA expectations for third party manufacturing and packaging vendors, perform strategic systems reviews and coordinate risk/benefit analyses of supplier processes and systems to assure compliance with cGMP’s and Takeda Quality System expectations
As necessary works with specific Takeda LOCs to assure compliance with country-specific requirements/regulations for the packaging of product for markets outside of the U.S
Develop audit expectations for third party manufacturing operations per TPUSA audit program, compliance needs and business needs and ensure completion of audits with Global Auditing Group. Lead audits of existing or new Takeda contractors or suppliers for due diligence activities, PAI to ensure compliance with Takeda Quality expectations
Develop and maintain a broad network of relationships within Takeda’s global environment. Represents Takeda and senior management at corporate and regional meetings and, as necessary, with Regulatory Agencies, industry groups and business partners
Manage staff responsible for ongoing compliance interactions with vendors and Takeda functions, to assure timely disposition of Takeda product while ensuring compliant operations. Make recommendations regarding long-range resource planning, budgeting and restructuring to meet Takeda and project needs. Adjusts functional or cross functional activities in response to or in preparation of changes in strategic direction
Provide leadership and oversightin the assessment of critical changes or deviations for Takeda products, to assure compliance to regulatory commitments, assessment and evaluation of risks, appropriate disposition of product and system correction or improvement of operations to minimize future risks
Maintains awareness of relevant legislation and regulatory guidelines and provides interpretation of regulations, and assures that QA vendor management programs, systems and controls are reviewed and updated as needed to assure compliance. As necessary, confirms requirements and regulations of other Takeda markets in support of TPUSA manufacturing and packaging activities. Monitors business environment at supply chain partners to ensure compliance objectives are met
Ensure successful and timely completion of all product submissions, launches and new Takeda initiatives within Takeda, as well as at our contract manufacturing, packaging and labeling operations
Assist with FDA or other regulatory inspections of TPUSA, other Takeda facilities or third party vendors associated with the commercial product supply chain. May represent Takeda during regulatory inspections, as needed
Identifies key trends and emerging issues at vendors and implements corrective actions as needed
Bachelor’s Degree in Chemistry, Engineering, Biology or related discipline and 12 years of QA/QC experience in the pharmaceutical industry and/or QA/QC laboratory environment
6 years of people management experience desired
Expertise in cGMPs, ICH and other pertinent regulations
Project Management expertise desired
Skills required

Associate Director, Quality Assurance Resume Examples & Samples

Assures that the Quality Operations department of the EP operates within established policies and procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.), both domestic and foreign
Assures the development and maintenance of a Quality Agreement with the EP’s. Acts as the Quality expert on Merck's behalf regarding contractual negotiations and provides input into the development of commercial contractual agreements with the EP on quality related terms
Executes a program of calibrated Quality oversight based on the product type, capabilities, and quality and compliance performance of the EP
Has responsibility for Quality assurance and control functions to include direct support to EP’s, coordination and oversight for product testing, as well as other relevant components as determined by applied calibrated Quality oversight
Has responsibility for maintenance and oversight of ongoing supplier performance management to include regulatory inspection support and monitoring, internal complaint management, internal customer feedback coordination, and review of annual product reviews
Reviews all audit outcomes pertaining to the EP’s and ensures appropriate and timely corrective actions are identified and implemented
Monitors efforts to improve the EP’s quality and reliability through ongoing oversight and formal communication programs and forums
Provides support to the EP’s to facilitate and validate new product introductions
Assists in the coordination of significant investigations including Fact Findings. Assists in the coordination of product recalls as needed
Operates in a safe and efficient manner and in compliance with the MMD Q.O. Safety and Health Policy
Closely collaborates with appropriate business and operations areas to achieve MMD and MSD objectives
Manages team of Quality Assurance professions as direct reports. Holds regular 1-on-1 meetings and Employee Development Plan discussions. Responsible for executing performance management process including objectives setting, objectives approval, objectives revision, year-end accomplishment evaluation, and performance discussions with direct reports
Exhibits Merck Leadership Behaviors and provides leadership example for team
Contributes to developing EQA budget and tracks and controls expenses as needed to meet EQA budget
Experience in supporting the manufacture of sterile products (technology OR quality OR operations role)
Effective written and oral communication, technical writing skills, interpersonal skills, facilitation and influencing skills with an ability to effectively drive results with stakeholders
Demonstrated ability to work efficiently under conditions of multiple deadlines and changing priorities

Associate Director, Quality Assurance Resume Examples & Samples

5+ years of experience within the Quality field (process improvement, quality assurance, audit, control)
3 years of healthcare experience
Strong analytical and negotiation skills with a proven track record for innovation successful outcomes
Prior experience in large, multi-function and cross geographic organizations
Advanced degree in a related field
Certificate or work experience in Lean

Associate Director, Quality Assurance Resume Examples & Samples

Under the direction of the process QA lead, provide input to and assist with the development of tools and techniques to assess, report and mitigate risk and issues with processes across MRL functional areas and partners. Work with other MRL QA groups to ensure that functional areas and process owners understand requirements set forth in the strategy
Monitor process performance through established performance measurements and assessment of existing data sources. Utilize performance results to improve the quality and reliability of processes. Provide support to the SQI process where applicable, under the direction of the process QA lead
Independently verify execution of the process quality strategy, supports departmental operational activities utilizing advanced competencies, knowledge and judgment; provide quality input for development of new processes and audits execution of existing processes
Serves as a source of information for process quality, risk assessment and regulatory requirements
Conducts appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable regulations, safety guidelines and company policies and procedures. May lead or assist with the preparation or review of relevant SOPs or policies relevant to MRL QA or partnering MRL organizations
Collaborate effectively across areas within MRL QA and MRL functional areas to help achieve quality goals and understanding of and application of appropriate regulations
Contribute to, or assist with the development of educational and training materials and sessions to further develop competencies or understanding across MRL QA and partnering MRL areas, where applicable
Minimum of 5 years QA experience or relevant experience in quality management, with a focus in the relevant area of responsibility
Understanding of and experience with risk assessment tools
Prior people leadership experience desired, i.e. project teams, direct reports, etc. with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities

Associate Director, Quality Assurance Resume Examples & Samples

Under the guidance of the technology QA lead, facilitate the development and implementation of tools and techniques to assess, report and mitigate risk and issues in technology used across MRL functional areas and partners. Work with other MRL QA groups to help ensure that key technology vendors understand and meet minimum requirements set forth in the strategy
Manage a team of professionals focused on verifying implementation and maintenance of quality technology solutions across the MRL functional areas through system assessments and audits. Provide guidance and direction to the team as appropriate to ensure appropriate priorities and consistent practice
Utilizes a team of professionals to help verify execution of the technology quality strategy, supports departmental operational activities utilizing advanced competencies, knowledge and judgment; Utilizing the team of professionals, participates in new technology assessments and represents MRL QA on governance committees as appropriate
Serves as source of knowledge for technology quality, risk assessment and regulatory requirements. Applies capabilities to enhance quality and builds capabilities of less experienced staff, as appropriate. Build effective working relationships with key technology owners and user groups; proactively provide quality input to system design and procurement (QbD)
Conducts appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable regulations (e.g., Part 11, Good Laboratory Practice, Good Pharmacovigilance Practice, Good Clinical Practice, Animal Welfare regulations), safety guidelines and company policies and procedures. May assist with the preparation or review of relevant SOPs or policies relevant to MRL QA or partnering MRL organizations
Collaborates effectively across areas within MRL QA and MRL functional areas to help achieve quality goals and understanding of and application of appropriate regulations
Contribute to, or assist with educational and training materials and sessions to further develop competencies or understanding across MRL QA and partnering MRL areas, where applicable

Associate Director, Quality Assurance Resume Examples & Samples

Provide input to the development of and ensure the implementation of tools and techniques to assess, report and mitigate risk and issues with vendors contracted across MRL functional areas and partners. Work with other MRL QA groups to ensure that vendors understand and meet minimum requirements set forth in the strategy
Under the guidance of the vendor quality lead, work with vendors and MRL functional areas to ensure implementation of quality plans, KPI’s and KQI’s, where appropriate. Assist with the integration of quality considerations into the vendor selection process
Independently verify execution of the vendor quality strategy, support departmental operational activities utilizing advanced competencies, knowledge and judgment; participates in new vendor assessments/qualifications and represents MRL QA on governance committees, as appropriate
Act as a source of knowledge for vendor quality, risk assessment and regulatory requirements. Build effective working relationships with key vendor quality representatives
Conducts appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable regulations, safety guidelines and company policies and procedures. May assist with the preparation or review of relevant SOPs or policies relevant to MRL QA or partnering MRL organizations

Associate Director Quality Assurance Resume Examples & Samples

Coordinate, prepare, and manage CMC (Quality) documentation for submissions and subsequent variations/supplements. This includes both post-market changes and routine annual updates
Review manufacturing/testing changes and provide regulatory impact assessments
Responsible for representing and supporting CMC regulatory/quality on multi-disciplinary project teams and providing quality and regulatory CMC guidance
Manage Life Cycle for products, including coordinating quality related activities
Provide technical support to investigations
Review and monitor ongoing studies
Write and edit documents in accordance with Common Technical Document (CTD) guidance and company standards
Prepare responses to health authority comments and questions
Participate in the development and maintenance of company-wide quality systems to ensure compliance to requirements throughout the organization
Support Annual Product Quality Reviews (PQR) for assigned projects by consolidation/ summarization of internal and contractor data. Assure timely completion and communication in alignment with procedures and Quality Agreements
Participate in or lead contractor audits and regulatory agency inspections, as required
Keep abreast of industry trends with respect to CMC regulatory policies and procedures
Minimum BA/BS in related scientific discipline (biology, chemistry, biochemistry, immunology, pharmacy)
15+ years' experience in Pharmaceutical industry with at least 7 years' experience in a quality, technical, or CMC regulatory position
Key knowledge of biological (protein) production, purification, and testing
Understanding of biologic regulations and eCTD filing requirements for the U.S. and the E.U
Demonstrated experience and leadership in managing quality and compliance activities in manufacturing
Demonstrated ability to work and draft documents in a fast paced environment
Flexible with respect to prioritization of daily tasks and projects according to internal and external influences
Knowledgeable of cGMPs, U.S. Regulatory requirements, 21 CFR Part 11, and EU requirements

Associate Director, Quality Assurance Resume Examples & Samples

Drive new QA processes for the department and continue the build-out of automation capabilities
Ensure everyone is fluent in all types of testing, especially non-functional, integration and regression
Lead client UAT sessions and oversee development of UAT scripts
Be a key individual on high complexity projects and an active contributor to ensuring a high quality product
Collaborate actively with other capabilities (Account, Creative, Project Management, etc)
Oversee a QA team in Chicago as well as Latin America and India
Promote continuous education through training and certification to keep QA skills sharp and modern

Associate Director, Quality Assurance Resume Examples & Samples

Oversees the department activities regarding quality operations and product release including: product quality, evaluation of batch records; CAPA investigations; qualification review and clinical release
Provides oversight for inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality
Approves specifications, sampling instructions, test methods and other procedures; ensures appropriate validations are done; authorizes written procedures and other documentation
Participates in continuous improvement efforts and implementing policy as part of a leadership team
Ensures that the required initial and continuing training of personnel is carried out and adapted according to need within requirements of GMP
Supervises work of others, including planning, assigning, scheduling and reviewing work, ensuring quality standards; responsible for hiring, terminating, training and developing, reviewing performance and administering corrective action for staff; plans organizational structure, position content and staffing
Must have experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve regulatory and compliance issues and to increase others knowledge of US end European GMP regulations and guidance
Must have the ability to utilize knowledge and interpersonal skills to provide leadership, direction and development cross-functionally and to direct reports
Must be a motivated self-starter; detail and results oriented; well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks
Has a thorough understanding of the regulatory process from CMC section of the IND through to commercial manufacturing
Must have knowledge of US and European Drug Product GMP requirements and associated guidelines
Minimum of 10 years’ experience in a Quality Assurance role in the pharmaceutical industry, preferably with parenteral dosage forms
Experience in developing and implementing a cGMP compliance program in association with bringing a product through clinical trials to commercialization

Associate Director, Quality Assurance Resume Examples & Samples

Direct final disposition of packaging and raw materials, intermediates, and finished products with total independence in the approval/rejection process
8+ years in pharmaceuticals or fine chemicals
5 years in Quality Management

Associate Director, Quality Assurance Resume Examples & Samples

Proven complex problem solving skills
Certificate or work experience in Lean/Six Sigma
Experience in Billing & Revenue Cycle

Associate Director, Quality Assurance GMP Resume Examples & Samples

Overseeing GMP quality assurance and compliance activities (internal and external) across all Ironwood R&D programs. This individual will set and meet objectives and expectations for quality systems of various Ironwood CMOs and other vendors
Interface with the CMC groups on the project teams and provide guidance to the teams as it relates to performing various GMP activities
Review and approve master and executed production batch records
Ensures that effective GMP quality processes and SOPs are in place for each functional area (CMC)
Provide guidance, support and training on interpretation of cGMP regulations, quality system requirements, corporate standards and policies
Provides recommendations for risk mitigation, continuous improvement and/or issue resolution
Responsible for escalation, management and resolution of significant manufacturing quality deficiencies. Ensures appropriate corrective and preventative action plans are defined and implemented
Ensures appropriate quality and compliance metrics are in place, are being measured, and are being consistently tracked and reported on
Review CMC sections of regulatory submissions for IND’s, CTA’s, NDA’s, etc. as assigned
Preparing and negotiating quality agreements with CMOs
Up to 15% scheduled travel may be required
A Life Sciences undergraduate degree is required
Ability to lead cross functional teams in various problem-solving activities, with the experience necessary to find creative, flexible and compliant solutions to a number of Quality challenges
Excellent understanding of Good Manufacturing Practices with the ability to lead and mentor junior members of the Quality organization in this regard
Experienced in phase appropriate application of the cGMP rules and regulations as they pertain to the R&D phases of the Product Lifecycle
Operational experience in developing and establishing operations quality systems
Demonstrated people leadership skills. Significant experience and success track record of line and cross-functional team management
Strong knowledge and significant experience with ICH, USP, 21CFR210, and 21CFR211
Previous experience in participation in regulatory agency inspections
Experience communicating with both domestic and international contract manufacturing organizations and has an awareness of cultural diversity
Demonstrate strong organizational and interpersonal skills
Build relationships with effective communication and influence
Proficient in resolving conflict, critical thinking and problem solving with a keen attention to detail
Strong work ethic and operates with a sense of urgency

Associate Director Quality Assurance Resume Examples & Samples

Work to understand processes, identify failure points, and develop quality assurance/audit programs to ensure operational excellence is achieved
Develop new workplace audits of processes to flag issues prior to having a member impact
Adapt departmental plans and priorities to address business and operational challenges
Collaborate with senior business leaders to deliver insight derived from data, highlight emerging trends, and work through implications business strategies
Identify and validate issues and root causes identified with business SMEs to obtain functional area ownership
Create and oversee process to conduct audits and provides feedback to reduce defects and improve processes and performance
Bachelor’s Degree in related field
5+ years of people leadership experience with team of 10 or more direct reports
3+ years of project management experience lead initiatives that require strong leadership and influencing skills
1+ years of experience with Six Sigma process improvement
Highly effective communication (verbal and written) and presentation skills with the ability to communicate to a variety of levels within the organization including executive leadership
Experience in large, multi-function and cross geographic organizations is preferred
3 years of Project Management expertise
Experience creating processes, guidelines, and procedures for Quality Assurance organizations
Advanced Degree in related field

Associate Director, Quality Assurance Resume Examples & Samples

Lead the development, implementation and execution of commercial product complaint process that is integrated with the pharmacovigilance, medical information and commercial intake processes
Lead the development and implementation of product complaint management system
Develop, deliver and track product complaint intake training for call intake center staff
Manage product complaint investigations, initiation through closure. Recognize and escalate any significant issues revealed at any point during the product complaint process
Track, trend and report on product complaint metrics
Business process owner for product complaint management system Manage and administer system roles for user access and periodic review of required system role and access
Assess and approve any changes to the system above, to assure validated state of the systems is maintained
Support inspection readiness plans and interact with regulatory agencies during inspections on product complaint-related matters, as needed

Associate Director, Quality Assurance Resume Examples & Samples

Remain informed of current GMP requirements and industry trends as described in applicable worldwide regulations and industry standards. Provide comments on proposed regulations and communicate impacts to client areas. Maintain an expert level of knowledge related to specialized area of technical expertise
Ensure departmental SOPs reflect departmental procedures and the current regulations. Responsible for oversight of SOPs in supported areas and ensure periodic updates, as appropriate
Manage the audit and/or approval of GMP documentation for applicable regulatory filings, clinical supply, development and technology transfer, facility and/or equipment qualification. Ensure compliance with regulatory and Merck requirements. Evaluate deficiencies and assess impact on compliance status
Coordinate preparations for regulatory agency inspections, as applicable. Accompany regulatory agency officials conducting inspections of facilities or operations in supported areas, including GMP Certification inspections and issue formal reports of inspection activities. Facilitate inspections by corporate auditors or external, non-government auditors in supported areas. Coordinate the drafting of responses to inspectional observations to satisfy Merck and/or regulatory agency requirements
Advise supported areas on the GMP compliance aspects of the design of facilities, selection of equipment (including computerized systems), preparation of departmental SOPs, quality practices, policies, and interpretation of applicable worldwide regulations
Act as Quality representative for in-house or outsourced manufacturing programs. Duties include compliance oversite of program-related activities, batch record review and approval, deviation and/or out-of-specification approval, etc
Support of Due Diligence/outsourced programs including travel to other countries (e.g., EU). Travel may be 5% depending upon program needs
Efficiently manage all activities within resource constraints while complying with all Merck policies and regulatory requirements
Develop/approve quality system and/or policy for Development Quality department as needed
Represent the department or area on project teams or committees establishing GMP, or quality standards, policies or expectations within Merck
Manage GMP audit/inspection program for facilities, systems (including computerized systems) and operations at contractors or licensees, engaged in the processing, testing, or holding of clinical supplies. Evaluate deficiencies and assess impact on compliance status. Issue reports summarizing deficiencies and work with departments to resolve such deficiencies. Notify appropriate Quality and support area management of compliance issues and performance trends
Specific and/or additional duties may include, but are not restricted to
Assess the suitability of GMP data and material potentially available for use in clinical trials through the establishment of license agreements and advise Senior Staff on recommendations. Work with licensee on the identification of information required for Merck reviews of such programs
Manage the clinical release or re-evaluation dating to ensure conformance to appropriate worldwide regulatory requirements
Pharmaceutical/biotechnology industry with five (5) years in a technical, quality, or compliance role
Direct or indirect management experience
Extensive working knowledge of cGMPs and technical aspects of support area are required
Effective communication, negotiation, problem-solving, and interpersonal skills with demonstrated project management abilities are necessary to perform job responsibilities
Previous experience required to perform job responsibilities may include: quality assurance, auditing, or regulatory submission requirements

Associate Director Quality Assurance Resume Examples & Samples

6+ years of leadership and management experience in Quality functions
Ability to interact effectively with senior management across departments
Contract Manufacturing Organizations management experience

Associate Director, Quality Assurance Resume Examples & Samples

Minimum five years prior supervisory experience
Minimum ten years experiences in pharmaceutical/biotech industry
Thorough knowledge of FDA, EU and ROW regulations and GLP, GDP, PV and GMP requirements
ASQ or other auditing certification a plus
Proficiency in English, other languages are an asset
Thorough understanding of regulations on Good Manufacturing Practices and Good Distribution Practices
Knowledge of medical/biological and cold chain products
Proven Leadership record
Working knowledge in ISO Requirements / Certification Process

Associate Director, Quality Assurance Resume Examples & Samples

Receipt of starting materials
Review batch-related documentation, and ensures resolution of issues to release product
Oversee the product disposition process
Oversee the packaging and shipping process
Ensure all product-related Deviations are initiated, investigated and resolved. Ensures that associated CAPAs are initiated and resolved, as needed
Chair the Material Review Board meetings as required
Ensure Change Controls are initiated, evaluated and implemented appropriately for all regulated changes
Develop and implement Quality on the floor processes, including batch record review
Ensure process control measures are in place and followed in product manufacturing
Maintain and report monitoring and control metrics for Quality Systems in support of the Management Review
Schedule staff to support manufacturing and packaging processes in order to ensure on-time delivery of product to patients
Recruit, train, manage, and develop staff

Associate Director, Quality Assurance Resume Examples & Samples

Plan, schedule, conduct, report and close audit activities
Assist in establishment of QA & control policy, provide consultation & recommendations to regional and Global QA Management
Serve as an author for QA SOPs, may act as regional QA representative to the global QA SOP taskforce
Host customer audits, participate in review of corrective action plans
Recommend systems for audit, write systems audit plans, coordinate scheduling, conduct, reporting and closure of internal system audits
Conduct trend analysis of audit results, provide QA mgmt with initial root cause analysis
Ensure proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory facility inspections
Participate in or lead (cross functional) teams for special projects as assigned
Manage staff; Responsibilities include planning, assigning, & directing work; appraising performance, guiding professional development; rewarding and disciplining employees; addressing employee relations issues & resolving problems. Approve actions on human resources matters
Considerable knowledge of quality assurance processes and procedures
Effective organization, communication, and team orientation and leadership skills
Ability to influence and guide others
Ability to manage costs effectively through appropriate resource allocation
Management experience in Quality Assurance
Bachelor’s/primary degree
10 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience; 3 years of management experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience

Associate Director, Quality Assurance Resume Examples & Samples

Lead the team and others by providing direction and guidance
Assign batch disposition product after a thorough assessment of the release inputs
Review and approve Investigational, CAPA, and Quality Notifications (QNs)
Take on project management opportunities by leading and participating in process improvement, learning events, or business support initiatives as guided or approved by Quality management
Lead the site internal audit program
Serve as the Subject Matter Expert for all release related matters
Interact with Vendors and Merck Supplier Development and Procurement Management for issues associated with incoming components
Review and approve Vendor Change Notifications
Review and approve Master Batch Records
Direct support of regulatory inspections and audits
Direct support of validation activities and all other associated Quality functions
Minimum of 8 years experience in pharmaceutical operations, technical services, and/or quality operations; Understanding and application of GLPs and cGMPs
Quality Control, Quality Assurance and/or Regulatory Compliance experience
Minimum of 2 years managerial experience
Identifies and resolves technical and operational problems
Collaborates with peers to resolve problems that cross into inter-related units

Associate Director, Quality Assurance Resume Examples & Samples

Carries out managerial responsibilities in accordance with the organization’s policies, procedures, including safety rules and regulations and state, federal and local laws
Oversees the administration of the manufacturing change control system
Ensures statistical evaluation of Manufacturing, Packaging, Validation, Laboratory Services, R&D and Quality data, and produces investigations/reports to communicate these findings to management
Oversees review and approval of validation documentation
Provides QA support for on time launches of new products
Develops and implements plans for the QA support of the business
Provides QA technical direction for new quality systems or enhancement to existing quality systems
Assures that technical assistance through application of statistical methods for determination of specifications, sampling and testing methodologies and inspection sampling plans is provided as needed
Provides technical leadership and guidance for troubleshooting and problem solving activities related to process and laboratory investigations
Coordinates with Operations Management to ensure compliance with and understanding of cGMPs, Company policies and practices, and safety procedures
Oversees manufacturing deviations, Quality Systems, to ensure compliance with cGMPs, SOPs, Company practices and procedures and governmental regulations
Oversees Batch record issuance, review, and release, finished goods batch record review, AQL Product Inspection, In process record review, sampling and sample delivery, Writing investigations, Change Control, CAPAs, and batch record database information management
Assures that QA resources have appropriate training and retraining, as needed
Reviews and approves protocols and reports relating to the following: process validation, equipment cleaning validation, computer system validation, manufacturing equipment qualification
Complies with all company policies and procedures, including safety rules and regulations
Pertinent Federal, International and State laws related to pharmaceutical manufacturing processes, laboratory operations, and cGMP investigations
Applied statistics including descriptive statistics, central tendency, distributions, regression analysis, process capability and hypothesis testing
Equipment, facilities and utilities required for the manufacture of pharmaceutical solid dosage forms
Problem solving techniques and investigation tools
Leadership skills and tools
Business, scientific and personal computer hardware and software applications
Business English, usage, spelling, grammar and punctuation
Supervision, team leadership and training practices and methods
Implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources
Operating personal computer and spreadsheet and specialized software
Leading, coordinating, delegating assignments and reviewing the work of assigned departmental personnel
Planning, establishing, monitoring and controlling resources
Guiding and directing the activities of subordinates
Demonstrating initiative and paying close attention to details
Communicates clearly and concisely, both orally and in writing
Managing and prioritizing multiple projects, duties and assignments
Direct experience with Health Authority Inspections (FDA/EMA,ANVISA, etc..) and Transdermal Manufacturing/Quality preferred

Associate Director, Quality Assurance Resume Examples & Samples

Provide guidance, interpretation, support, training, and key input to clinical development operational staff on interpretation of GCP regulations, guidelines, corporate standards, and policies
Conduct trend analysis of audit results and provide QA management with initial root cause analysis
Recommend staff management actions in accordance with organization’s policies and applicable laws. Recommendations include training, coaching, and mentoring employees; planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems
A minimum of 3 years of management experience; or equivalent combination of education, training and experience

Associate Director, Quality Assurance, CMO Resume Examples & Samples

Develop and implement quality systems SOPs and processes to manage oversight of CMOs and critical suppliers
Review/approve critical GxP controlled documents i.e., master and executed batch records, test methods, specifications, change controls, deviations, CAPA, laboratory investigation, design control, drawings and other documents as applicable
Develop and implement qualification/certification program for CMOs and critical vendors for reduced batch record review, testing and risk based audits
Act as the key point of contact and liaison between Intarcia and CMO for all quality related matters
Collaborate with quality management to establish technical quality agreements with critical suppliers, CMO’s, service providers, test laboratories, and distributors providing critical materials and/or services to Intarcia
Manage product quality incidents and CAPA associated with materials and/or services provided by our suppliers including supplier corrective action reports (SCARs)
Create key quality metrics for tracking and trending critical KPI quality data and compile Annual Product Reviews for all CMOs
Conduct CMO gap assessments in support of the supplier qualification program and inspection readiness preparations
Responsible for presenting Intarcia’s CMO oversight and qualification program to regulatory agencies including interacting with regulatory agencies during inspections on supplier QA related matters
Collaborate with External Manufacturing, Materials Management, and Quality to ensure vendor compliance to Intarcia quality requirements and regulations and recommending changes (as required)
Conduct external audits of critical vendors and CMO’s
Manage other QA responsibilities in GMP functions, as assigned by the Supervisor
A minimum Bachelor’s degree in a scientific discipline is required. An advanced degree is preferred
A minimum of 15 years’ experience with extensive knowledge and experience in managing and oversight of CMO’s and CTL’s in a highly regulated manufacturing environments
Seasoned professional in managing GxP Quality Systems for drug/device combination aseptic products
Strong working knowledge of cGMP global regulations (21CFR210, 211, 820, 4), ISO 13485, CE Marking and ICH guidance’s
Experienced and certified quality auditor with proven track record in negotiating quality agreements, reviewing GMP documents, and supporting QA in conducting supplier audits
Experience in dealing with global regulatory agencies, supporting and hosting inspections (as required)
Hands on execution of all aspects of supplier quality assurance functions in an entrepreneurial, fast paced environment
Strong leadership ability, interpersonal, communication, and influencing skills required
Strong verbal, written communication skills and computer skills (Microsoft Excel, Word, Visio, MS Project and PowerPoint) are required
Must be able to travel (15 - 40%)

Associate Director, Quality Assurance Resume Examples & Samples

Coach and manage a team of varying skill levels in product workflows, critical thinking, problem solving and best practices
Be point of contact for the QA team's critical role in a given product area; daily scrums, sprint planning, retrospectives, and reviews
Coordinate test strategy, planning, and execution; ensuring adequate staffing to support the QA efforts
Build reports and enhance visibility into working aspects of the QA process and quality of product
Guiding and implementing automation and regression testing scenarios and approving testing plans for team members
Participate in the interviewing process of future QA members: Leads, Sr. Engineers, Engineers, and Associates
Bachelor’s Degree in Computer Science or similarly technical/quantitative field. Masters Degree a plus
6+ years of experience within Quality Assurance field, with at least 1-2 years in a managerial/lead role
Hands-on experience in C# and .NET, scripting languages, and SQL databases
Familiarity with test case management and automated testing tools such as MSTest, Specflow, TestComplete, Quality Center
Understanding of the financial technology space a plus
Analytical thinking and problem solving abilities and experience in managing difficult situations
Experience working within a cross functional environment with remote teams

Associate Director, Quality Assurance GCP Resume Examples & Samples

Plan, schedule and conduct audits of Clinical Investigator Sites, CROs, and Clinical submission documents
Assist in development and review of responses and corrective actions related to audit activities and reports
Actively manage GCP advice and support to client's Development Operations and other relevant Clinical functions
Stay abreast of clinical trial requirements, FDA, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the US/EU and other regions, as appropriate
Assist in the review and revision of Clinical Development and QA SOPs
Conduct GCP training for client's staff
Alert QA GCP Management of internal and external GCP compliance and clinical trial issues in a timely manner
Assist in risk identification and suggest mitigation plans related to assigned projects
Become thoroughly familiar with assigned client compounds and protocols
Provide support for regulatory authority inspections including conducting pre-inspection audits of sites, CRO’s and processes
Assist with the management of QA consultants performing audits on behalf of client