Director, Quality Systems Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the director, quality systems job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies

Tailor your resume & cover letter with wording that best fits for each job you apply

Resume Builder

Create a Resume in Minutes with Professional Resume Templates

CHOOSE THE BEST TEMPLATE - Choose from 15 Leading Templates. No need to think about design details.

USE PRE-WRITTEN BULLET POINTS - Select from thousands of pre-written bullet points.

SAVE YOUR DOCUMENTS IN PDF FILES - Instantly download in PDF format or share a custom link.

Create a Resume in Minutes

P Boyle

Paul

Boyle

93272 Huels Plaza

Phoenix

+1 (555) 472 4843

93272 Huels Plaza

Phoenix

Phone

p +1 (555) 472 4843

Experience Experience

Dallas, TX

Director, Quality Systems

Dallas, TX

Crist Inc

Dallas, TX

Director, Quality Systems

Proven track record in people management (developing, coaching, mentoring, directing) and budget management
Represent company in interactions with customer meetings, sales support requests and trade associations, such as Independent Marketing Alliance (IMA), Markon Produce, National Restaurant Association (NRA), International Food Distributor Association (IFDA), etc
Builds strategic partnerships to further Quality organizational objectives and collaborates with all levels in developing strategic direction for short and long term business planning
Partners with management in the development and introduction of new products and processes into manufacturing through quality planning including verification and validation
Participates in 2nd party agreements (e.g. contract mfg, distribution, acquisitions etc.) through due diligence activities of quality system assessment, contractual agreement, and quality system integration
Coordinate quality and food safety expectations, compliance activities and quality improvement initiatives with partner groups such as Independent Marketing Alliance (IMA) and Markon Produce
Instill robust corrective action tracking and proactively identify gaps in quality system to minimize food safety and customer quality concerns. Participate in cross functional Supplier and Co-pack selection, approvals and compliance

San Francisco, CA

Associate Director, Quality Systems

San Francisco, CA

Stracke-Hackett

San Francisco, CA

Associate Director, Quality Systems

Proactively identify, develop and implement areas for work process improvement and efficiency
Enhance and develop quality risk management tools and methodologies and apply to the commercial quality system
Collaborate with IT in identifying and developing continuous improvement opportunities in Ironwoods validation programs, policies and procedures
Drive continuous improvement efforts of the Stemcentrx Quality Management System
Compile data, analyze data, draw data driven conclusions and develop risk based action plans through the CAPA system for management review outputs and annual product quality reviews
Author quality system trend reports and develop metric control plans for management review reporting
Partner with the functional areas of Manufacturing, Facilities, QC, and Engineering to drive closure of Deviations, CAPAs, Investigations, Complaints, and Change Controls

present

Detroit, MI

Senior Director Quality Systems

Detroit, MI

Simonis, Barrows and Gerhold

present

Detroit, MI

Senior Director Quality Systems

present

Establishing, implementing, and maintaining a comprehensive and risk based Validation program with comprehensive and completed lists of validated equipment, utilities, processes, methods, and computerized systems for the site
Ensuring equipment, utilities, processes, methods, and computerized systems for the site are validated to current standards and are maintained in a validated state
Ensuring changes to equipment, utilities, processes, methods, and computerized systems for the site are documented, assessed, tracked and approved in a compliant Change Control system
Implementing the Company Quality Management System and leads the Quality Management Review process
Replacing, updating, and enhancing Quality Related IT systems and databases (e.g. Change Control, Discrepancy/CAPA, Batch Record issuance and tracking)
Establishing and maintaining a compliant and efficient document management process and system
Ensuring the timely creation and approval of an Annual Product Review for each product produced at the site

Education Education

Bachelor’s Degree in Engineering

San Diego State University

Bachelor’s Degree in Engineering

Skills Skills

Proven leader with excellent collaboration and teamwork skills, including the ability to nurture a strong food safety culture
Strong overall business acumen and ability to implement corporate and divisional strategy
Knowledge of FDA, ISO, GMP/QSR and other Quality system recognized standards
Ability to work with outside suppliers, medical and technical professionals
Strong relationship skills to achieve sustainable partnerships and collaboration internally and externally
Strong interpersonal, verbal and written (including email) communication skills with professional demeanor
Good management and strong communication skills
Proven leadership skills related to quality assurance and food safety in a manufacturing environment
Demonstrated ability to successfully direct multiple functions in establishing and delivering consistent results. Timeline and performance driven
Ability to handle a variety of projects and coordinate the efforts of direct reports at the same time

Create a Resume in Minutes

15 Director, Quality Systems resume templates

Read our complete resume writing guides

Director, Quality Systems Resume Examples & Samples

BS degree -required in chemistry, microbiology or chemical engineering; Advanced degree is preferred
ISO Certified Auditor and or Black Belt/Green Belt preferred
Requires a minimum of 10 years of experience in pharmaceuticals or cosmetics including holding recent management or executive level positions
The incumbent must be sufficiently knowledgeable to direct staff in product or process problem solving
Must possess in-depth knowledge of current regulations, guidances and regulatory agency This would include in-depth knowledge of recall regulations
A strong understanding of inspection techniques, including quality engineering principles and statistical methodology is
Strong software system skills are required
The incumbent must possess good interpersonal abilities to work with general managers, commercial and operations leaders across the respective business units
Incumbent needs to possess excellent people skills to influence, motivate, teach and encourage direct staff as well as peers to understand and accept his/her

Director, Quality Systems & Compliance Resume Examples & Samples

Performs all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements
Implements site programs and quality systems to improve knowledge and understanding of compliance requirements at all Alexion and contractor sites. Identifies compliance gaps and develops and implements plans to resolve issues and mitigate compliance risks
Provides strategic direction to area personnel responsible for the quality management systems
Leads and manages inspection readiness programs of all Alexion facilities including hosting consultant visits, preparation activities and managing project plans. Develops and maintains GMP Compliance Training Programs (procedures, records) to support inspection readiness at all sites
Plans and manages strategy for all Alexion US regulatory inspections, including inspection process, regulatory interactions, providing strategic direction to staff to defend practices, approval of inspection responses and tracking corrective actions to closure. Ensures that post inspectional commitments are tracked and completed on time
Provides guidance to all Alexion US facilities on interpretation of international regulations and provides regular updates on industry trends and their application to Alexion sites. Implements corrective actions as required
Responsible for reporting requirements to regulatory agencies and leads implementation of corrective actions and quality system improvements
Develops and implements a risk-based audit programs that meet regulatory requirements. Ensures adherence to a pre-approved audit schedule and ensures auditor qualifications allow accurate assessments of site compliance and risks
Drives the development and continuous improvement of compliance initiatives. Manages development and maintenance of systems for tracking and trending pertinent compliance data for quality system performance and/or improvements. Provides recommendations to Senior Management
Establishes realistic goals and objectives. Plans and directs work activities, and continuously monitors progress such that responsibilities goals and objectives are accomplished efficiently, completely and within established timeframes. Assures that work is performed in compliance with department SOPs and cGMPs
Interacts effectively with site and company management and internal departments to ensure compliance requirements are understood and adhered to
10+ years leadership experience in a QA/Compliance role
Thorough knowledge of international regulatory requirements for biotech products and extensive experience in interactions with regulatory agencies

Director Quality Systems Resume Examples & Samples

Leads and ensures compliance with cGMP’s, DEA and OSHA regulations on the production shifts
Partners with manufacturing in ensuring cGMP compliance, as well as delivery of quality products, including improvement efforts in quality production
Oversees and manages the CAPA (corrective action, preventive action) system. Ensures actions and follow up are executed in a timely manner
Manages and develops new functionality as the system owner for the Document Management software system
Leads and manages the batch packaging Deviation program
Leads the Quality Systems team through direct management of the Sr. Quality Systems Managers who oversees the shift Quality Managers in production
Serves as lead regulatory escort, performs escort duties with contract packaging customers and FDA during audits
Leads and manages the supplier audit/certification program
Responsible for leading the efforts and compliance with Lean Six Sigma practices for the department. Provides support to continuous improvement activities as needed
Functions as back up to departmental Sr. Director of Regulatory Affairs or Vice President of Regulatory Affairs and Quality Systems when needed
BS in a scientific discipline preferred; minimum of five (5) years in a cGMP facility in a Quality Assurance/Quality Control role
Certified LSS Black belt
Excellent oral and written communication skills. Ability to interact and communicate with staff at all levels
Ability to effectively lead, manage and participate in cross-functional problem solving teams; advanced collaboration skills
Advanced computer skills required
Ability to read and understand the English language for the purpose of following instructions
Ability to work independently, as well as within groups

WW Director, Quality Systems Resume Examples & Samples

Provide program leadership and direction to assure optimal execution of related programs and assure the QMS goals are achieved at all levels – DePuy Synthes segment, operating company and site - and they are aligned with those of the J&J Enterprise
Develop and Execute the Quality Management Systems strategy and standards for DePuy Synthes related but not limited to Quality Manual, QSMR, CAPA, and all other elements of the quality systems regulations globally as applicable
Oversight and management of all Information Technology (IT) solutions supporting the Quality Management System
Establish and maintain the QMS and related IT strategy roadmaps to drive growth and value for DePuy Synthes in all aspects of the business impacted by the quality system
Liaise with IT and IT Services departments to ensure adequate support is provided for existing technologies
Create the business cases and value propositions for programs and manage capitol appropriation requests and project budgets
Provide quality system subject matter expertise to the business and to the execution of related initiatives and external regulatory audit support
Collaborate with technology vendors to develop future capabilities in support of the segments long-term strategy
Champions the creation and maintenance of Credo based environment in his area of responsibility, living Credo values, building trust and caring for people
Develop and executes plans for talent attraction, development and retention to enhance the talent pipeline
Establish and maintain QS procedures and controls to ensure that the quality and performance of the product conforms to specified company standards and comply with the recognized Regulatory Standards for all markets in which our products are sold
Support DePuy Synthes objectives while adhering to the values of the Johnson & Johnson Credo and local safety and environmental policy and procedure
A minimum of a Bachelor's degree is required, preferably in an Engineering, Life Science, or related discipline. A Master’s degree would be an advantage
A minimum of 10 years of quality and/or manufacturing experience in medical device field is required. A minimum of 3 years of people management experience is required
Experience in Project Management, preferably related to Information Technologies/Data Management systems is highly preferred
Working knowledge of Quality System processes required by 21 CFR Part 820, ISO 13485:2003 & CFR Part 11 regulation is required
Strong communication, influencing and leadership skills. Ability to communicate at all levels of the organization is required. This candidate must be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as Operations, Regulatory, Research and Development and Procurement
This candidate should have a proven track record implementing Quality System improvements to meet compliance and overall business goal is required
Demonstrated expertise in interpretation and pragmatic application of QA standards is preferred. Initiative in innovative approaches to QA solutions and applications in a fast paced changing global business environment are preferred
The ability to continuously assess the effectiveness of functional processes and lead progressive improvement initiatives is required
The ability to influence at senior levels and across functions building strong networks internally and externally is required. Experience delivering results through influence in a highly matrix environment are also required. Strong experience and proven record motivating leading and developing staff, in a highly changing environment is required. Must be a proven change agent
This position can be located in Raynham- MA, West Chester- OH, Warsaw- IN, Leeds- England, or Cork- Ireland and will require up to 40% domestic and international travel depending on the location of the role

Associate Director Quality Systems Resume Examples & Samples

Thorough understanding of regulatory requirements for drugs, devices, biologics, including risk management
5-10 years of manufacturing and/or quality operation management experience (or equivalent) within an FDA and/or EU pharmaceutical, device and biologics environment
Ability to accurately interpret and apply regulatory expectations to the QMS in a drug, device and biologics manufacturing environment
Must have strong project management and communication skills
Model behaviors consistent with Merck’s Leadership behaviors, values and culture

Senior Director Quality Systems Resume Examples & Samples

Establishing, implementing, and maintaining a comprehensive and risk based Validation program with comprehensive and completed lists of validated equipment, utilities, processes, methods, and computerized systems for the site
Ensuring equipment, utilities, processes, methods, and computerized systems for the site are validated to current standards and are maintained in a validated state
Ensuring changes to equipment, utilities, processes, methods, and computerized systems for the site are documented, assessed, tracked and approved in a compliant Change Control system
Implementing the Company Quality Management System and leads the Quality Management Review process
Replacing, updating, and enhancing Quality Related IT systems and databases (e.g. Change Control, Discrepancy/CAPA, Batch Record issuance and tracking)
Establishing and maintaining a compliant and efficient document management process and system
Ensuring the timely creation and approval of an Annual Product Review for each product produced at the site
Assisting with the remediation of Quality Systems in association with the consent decree work plan
Focusing internally and externally; interacts internally with subordinates, peers, and senior management and interacts externally with regulators, customers, and contract manufacturers
Maintaining an external network of expertise and represents the division and company in professional organizations
Providing effective leadership including: developing and implementing objectives and business strategies; selecting key personnel and motivating members of the functional area; challenging employees to develop as leaders while serving as a role model and mentor; assisting with performance calibration/talent pool management/succession planning; individual goal setting/performance reviews; training and development; supporting workforce diversity, quality and safety and supporting supervisors/managers in the management of their employees/department which support achievement of individual/department/business objectives
Establishing departmental and individual goals and objectives in alignment with site goals and priorities. Identifying performance improvement targets and metrics. Ensuring capabilities and capacity in place to effectively deliver on all departmental commitments and performance targets
Strengthening overall leadership and organizational capabilities in area of responsibility. Building and sustaining high performance management team and ensuring strong alignment and coordination with other functional groups at the site
Ensuring effective utilization of resources by ensuring robust employee development, performance management, succession planning, and rewards and recognitions practices in area of responsibility
Managing headcount and expenses in area of responsibility to meet approved spending plan while achieving all departmental commitments and project objectives
Motivating, retaining and developing key employees. Building and sustaining employee engagement by creating an environment within which individuals and teams can excel
Interacting closely with BU, relevant sites and functions to define production plans, yearly goals and budgets for reporting functions/operations as well as long range plans (LRP and LRCP)
Bachelor's Degree in a science or technical field and12 years of experience in pharmaceuticals or a related industry with 10 years in management position
Knowledgeable of biotechnology processing and testing
Validation expertise with equipment, utilities, processes and computerized system
Expertise in document management systems
Thorough knowledge of GMPs
Expertise and knowledge in GMP engineering facilities and equipment design concepts in order to review engineering projects for compliaace impact
Knowledgeable of requirements for post approval changes and of information typically found in the CMC sections of regulatory submissions
Knowledgeable and experienced with discrepancy investigation and lot disposition
Skilled in achieving results and managing others to achieve corporate, site, and departmental objectives. Excellent collaborator
Excellent communication skills, good presentation and influencing skills and the ability to interact and gain the support of senior management
Driven with a strong focus on goals

Associate Director, Quality Systems Resume Examples & Samples

Implement and maintain systems, programs and processes to ensure compliance with GMP Quality functions through Phase 1/2 clinical manufacture at Stemcentrx’ internal manufacturing plant
Write and revise compliant Quality SOPs
Manage deviations, CAPAs, complaints, change controls, and document management per the Stemcentrx Quality Management System to comply with applicable company, US and EU regulatory requirements
Partner with the functional areas of Manufacturing, Facilities, QC, and Engineering to drive closure of Deviations, CAPAs, Investigations, Complaints, and Change Controls
Drive continuous improvement efforts of the Stemcentrx Quality Management System
Partner with IT to manage the implementation, validation and oversight of an Electronic Quality Management System (EQMS)

Director, Quality Systems Resume Examples & Samples

Responsible for implementing and maintaining the effectiveness of the quality system including the resources to establish and support it
Ensures the systems necessary to support effective application and monitoring of the quality system are implemented
Provide leadership and technical direction to quality systems department staff in achieving department strategic, tactical, and quality goals and objectives
Partner with outside suppliers and contract manufacturers; oversee and communicate the progress of production and quality projects to senior management
Oversee and review non-conformances, deviations, and investigations to ensure corrective actions are implemented and process improvements are realized
Establish and implement an internal and supplier quality audit program to ensure product specifications are met
Ensure all quality system records, policies and operating procedures are appropriately maintained and archived
Establish methods to monitor and communicate quality performance results
Define and closely monitor short and long term quality objectives and increase quality awareness
Assist with new product development and identify and justify enhancements for improved throughput, cost, and/or quality

Associate Director, Quality Systems Resume Examples & Samples

Review and approve critical Quality complaints and Investigation extensions
Support stock recovery activities
Minimum 12 years experience in Pharmaceutical or related industry
Strong leadership skills for the ability to lead teams of a cross-functional and multi-level nature, including senior management representatives
Previous GMP Quality role (quality Systems, validation, compliance, audit, assurance)

Director, Quality Systems Resume Examples & Samples

Identify and develop Policies and Procedures that include the Food Safety, regulatory and quality requirements needed for all manufacturing sites
Maintain a process for approving, issuing and annually reviewing all Food Safety/Quality Policies and Procedures
Manage the process for approval for all documents; reviewing procedures with affected departments for input or when differences of opinion arise
Develop and maintain a SharePoint site, policy/procedure quality index and manual for Corporate Policies and Procedures and one for each manufacturing site
Provide Policy/Procedure education and training for manufacturing sites
Provide leadership in Special Situations/Escalated Events, i.e. data gathering, RFR development and submission, interfacing with FDA and State agencies
Manage Crisis Commander for Special Situations – meeting notifications, contact lists, meeting notes, data upload
Maintain SQF/BRC Audit schedule for manufacturing sites
Maintain QI metrics and issue monthly reports
Proven leadership skills related to quality assurance and food safety in a manufacturing environment
Management of multiple and conflicting priorities
Proven track record in people management (developing, coaching, mentoring, directing) and budget management
Strong relationship skills to achieve sustainable partnerships and collaboration internally and externally
Excellent negotiating skills when working through conflict resolution
Demonstrated ability to successfully direct multiple functions in establishing and delivering consistent results. Timeline and performance driven
Proficient in Microsoft Office products

Director, Quality Systems Resume Examples & Samples

Develop and implement Quality System policies, procedures and processes that meet all applicable regulations and standards for product safety and effectiveness
Advise BAS management board in compliance decisions and actions regarding product remedial actions, including recalls and/or regulatory citations
Execute Field Actions and Recalls based on completed Remedial Action Plans
Engage and support investigations of product quality issues
Provide mentoring and leadership to the Quality Managers in Quality Assurance and/or Compliance areas
Provides timely information to department and divisional management on issues which will affect the division's Quality Systems performance
Coordinates resource allocation to insure appropriate quality support for new product development teams and BAS operations
Develop and monitor departmental budgets
Responsible for division Quality system and product failure investigations Establishes key performance indicators for the Quality engineering and ensures support of BAS operational objectives
Provides Quality Assurance support during FDA, corporate and notified body inspections/assessments during Quality Systems reviews
Develops, maintains, and implements department and division policies and procedures
Assesses priorities and makes project assignments for employees to assure division and corporate Quality priorities are met
Performs job reviews, recommends salaries and promotions, hires employees, and initiates disciplinary actions
Participates in training and provides input to training of other employees on division procedures and policies, technical and managerial skills
Maintain product risk files and management assessment for all products at BAS. Manage field assurance and document control functions
Provide risk assessment reports to divisional management and Corporate RSSS to ensure all new products meet compliance to quality systems
Ensure that employees are trained, motivated, and have work direction, and that divisional and corporate business and quality objectives are met
Bachelor's Degree with preference in Engineering, Statistics, or one of the Life Sciences
Eight (8) years progressively more responsible management experience in the medical device industry or equivalency in Quality Engineering/Quality Assurance
Demonstrated human relations and communication skills
Experience working in cross-functional team environment and a multi-level corporate environment
Masters of Science in Engineering or Life Sciences
Good management and strong communication skills
Ability to handle a variety of projects and coordinate the efforts of direct reports at the same time
Ability to work with outside suppliers, medical and technical professionals
Strong Project management skills
Strong leadership and decision making skills
Ability to work with all levels employees
Ability to analyze and use technical data
Strong overall business acumen and ability to implement corporate and divisional strategy
Knowledge of FDA, ISO, GMP/QSR and other Quality system recognized standards

Director, Quality Systems Document Control Resume Examples & Samples

University degree required
Minimum of 7 years quality assurance experience in the pharmaceutical industry
Demonstrated leadership skills, including the ability to lead and manage projects and staff in a matrixed and global setting
Experience in managing a Quality System within a Pharmaceutical environment. Comprehensive knowledge of GxP and other pertinent regulations and understanding of global quality standards relating to product development, submission and/or commercialization
Demonstrated ability to assess the state of current business and QA operations to identify and recommend future state, improvements, and to implement action plans
Demonstrated experience facilitating and leading global process improvement and harmonization activities
Demonstrated competence to resolve complex and diverse problems with decision making responsibility that has a major impact within Quality and/or with functional groups globally
Effective written and oral communication and interpersonal skills, facilitation and influencing skills with an ability to interface globally across multiple departments and across various levels of management with Astellas and with external stakeholders
Demonstrated experience leading strategic development and successful execution of plans and initiatives for addressing complex and diverse Quality matters
In-depth experience with Document Control systems, principles, and regulatory requirements and expectations
Able to meet the availability requirements of the position and can travel for business needs as required: approximately 20%
Experience in reviewing validation documents for an electronic document control system

Director, Quality Systems Resume Examples & Samples

Effectively control the deployment of business strategies, the utilization of personnel and the scope and timeliness of responses
Builds strategic partnerships to further Quality organizational objectives and collaborates with all levels in developing strategic direction for short and long term business planning
Works to achieve the overall objectives of the company and ensures that quality strategies are aligned throughout the region for the areas of responsibility
Oversees the quality system compliance through Global KPIs to monitor performance of key elements of the quality system according to internal and external requirements
Accountable for Global Management Reviews – provides management with objective evaluation of overall Global QARA performance and provides guidance for implementation of improvements, corrective and preventive actions related to processes that affect Haemonetics Quality System
Working with site and corporate management, ensures the effective implementation and maintenance for Quality System requirements, including but not limited to, MDD 93/42/EEC, ISO13485, CMDR, and 21CFR 820. Ensures organizational compliance with Quality Systems procedures and regulations
Translates Quality System strategy into tactical plans and ensures implementation
Partners with management in the development and introduction of new products and processes into manufacturing through quality planning including verification and validation
Participates in 2nd party agreements (e.g. contract mfg, distribution, acquisitions etc.) through due diligence activities of quality system assessment, contractual agreement, and quality system integration
Responsible for professional development for the Quality Systems group

Associate Director, Quality Systems Resume Examples & Samples

Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles
Strong knowledge of GMP, SOPs and quality systems
Identifying, writing evaluating and closing CAPAs and experience with internal and external audit principals
Strong knowledge of aseptic manufacturing processes
Strong knowledge of change control practices/strategies
Equipment and utility IQ/OQ/PQ/PV
Proficient in MS Word, Excel, Power Point and other applications
Ability to communicate and work independently with scientific/technical personnel
Required: Minimum of 8 years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product). Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, ICH 10)
Minimum 3-5 years of management experience
Education: Bachelor’s degree in technical discipline (Chemistry/Microbiology/Engineering or similar)
Preferred: Experience in the medical and/or pharmaceutical industry. ASQ certifications

Director, Quality Systems Compliance Resume Examples & Samples

Acts as Global Owner of the Janssen Adopting Regulatory Requirements (ARR) process. Leads cross-functional Council meetings and drives process improvements to ensure monitoring, identification, assessment, and implementation of new or revised regulatory requirements and standards impacting Quality Systems. Develops and reports metrics to ensure management awareness of risks and adherence to the process
Leads implementation initiatives for new or revised external standards and regulations impacting Global Quality Systems. Develops and manages cross-functional matrix teams to ensure gap and impact assessments are executed and remediation plans are in place. Develops and reports metrics to ensure management awareness of status
Manages the process for deployment of internal J&J Standards into the Pharmaceutical Segment. Identifies Process Owners and Functional Area representatives, trains owners on requirements for Sector-level assessment, and monitors the status of gap assessment and deployment across end-to-end functions of Janssen
Participates in Enterprise Regulatory Outreach forum as a key link between Pharma, J&J Regulatory Compliance, and other Segments across J&J
Participates as Pharma representative on Enterprise alignment projects related to external standards monitoring and audit standardization. Works to simplify and standardize processes across Janssen
Leads integration activities to assure inclusion of new/emerging regulatory requirements (e.g combination products) into applicable Janssen Global Quality Systems and internal audit processes
Ensures internal audit procedures remain current and up-to-date, and all applicable global and virtual organizations are subject to appropriate audit cadence. In partnership with J&J Regulatory Compliance, ensures audit planning and execution to ensure compliance with J&J policies
Plans and manages budget
As needed, provides compliance support in relation to new or emerging regulations (e.g. awareness training, supporting the development of remediation plans, attending and presenting at external conferences to shape external environment, etc.)
A minimum of a Bachelor’s Degree with at least ten (10) years of related experience in the pharmaceutical or similarly regulated industry is required
Experience in both medical device and pharmaceutical industries is preferred
Minimum of five (5) years of experience working with Quality Systems is required (change control, CAPA, audit, etc.)
Current Auditor Certification (CQA, ISO Lead Auditor, etc.) is strongly preferred

Director Quality Systems Resume Examples & Samples

Develops and implements best-in-class quality management systems policies, processes and procedures in accordance with appropriate standards, requirements and regulations globally
Leads organization to simplify, consolidate, and harmonize existing Quality Systems within Dental Platform to achieve business objectives
As an SME, provide quality systems expertise throughout the organization and drive continuous improvement to ensure effectiveness quality system is maintained
Assists in preparation for and support of external regulatory audits including FDA, notified bodies, etc., as well as internal audits
Participates in platform RAQA level Policy Deployment, leads implementation of key quality objectives and plans
This role is based in Orange Ca, and works within a cross-functional, matrixed global organization to drive dynamic performance in all areas
Proven ability to establish strategy and to translate it into an effective, long-term action plan
Comprehensive knowledge and experience with global regulatory requirements and product registrations
Possess strong negotiation skills, the ability to interpret and apply regulations, and working knowledge of product development process
Demonstrates knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971 and other applicable standards and regulations
Possess a broad knowledge of surrounding areas including Quality Assurance, Manufacturing and Development

Director, Quality Systems Resume Examples & Samples

Support Corporate and Supplier quality audit programs. Ensure that the audit programs are maintained as required by internal policies and procedures
Provide oversight, manage and coordinate the global change control and customer notification process
Oversee the Supplier Nonconformance process and ensure that supplier provides acceptable response to West’s complaint in a timely manner
Support the Quality Management System Documentation in general and assure that the procedure requirements are developed and fulfill the policy guidelines of West QMS and Regulatory requirements
Manage the customer specification review process and provide instructions when discrepancies are identified, so the specification can be mutually agreed to
Support the Material and Supplier Qualification process. Evaluate the change notification associated with supplier changes and collaborate with other departments to address the changes in a timely manner
Interface with customers for quality issues, technical information, specification, agreements, etc
Coordinate with appropriate personnel/areas to identify new/ongoing projects for product and process improvement activities and support the completion of them in a timely manner
Minimum of 8 years of experience in quality related field
Demonstrate team building and problem solving skills
Familiarity with tools, concepts and methodologies of quality systems
Knowledge of cGMP requirements and ISO standards

Associate Director, Quality Systems Resume Examples & Samples

Provide Quality validation leadership support as the Quality – IT liaison for computer system assessments, validation and change control, and provide effective Quality support for process improvements and compliance governance at all applicable support points of the System Development Lifecycle (SDLC). As required, support other non-GxP Ironwood systems validation and deployment activities to ensure consistency in approach of validation program protocols and execution
Provide validation support for IT change management documentation review. Ensure Quality & Compliance requirements are considered in any IT change initiative or GxP change request
Lead and perform Quality risk assessments and vendor audits of electronic system vendors, to ensure quality oversight and routine periodic review of vendor compliance performance
Provide CSV support during regulatory inspections and be able to articulate Ironwood’s application of Regulatory and Industry standards to its System Development Lifecycle (SDLC)
Perform timely and effective QA review of validation documentation such as SOPs, Validation Plans and Reports, Traceability Matrices, Testing deliverables, and Data Migration Plans
Collaborate with IT in identifying and developing continuous improvement opportunities in Ironwoods validation programs, policies and procedures
Proactively provide suggestions for solutions to process issues, and collaborate with appropriate stakeholders to drive productively towards completion and execution of solutions
Provide timely updates on projects and deliverables to Quality Management and any other functions that support IT validation project deliverables
Establish effective cross-functional partnerships with key internal stakeholders including IT, nonclinical research, clinical, pharmaceutical development, regulatory and global manufacturing teams and key external stakeholders including Business Partners, and vendors, as required
Bachelor’s degree with at least 10-12 years’ experience in the pharmaceutical industry, including proven experience in managing validation programs
In-depth knowledge of quality systems principles and applications to the pharmaceutical industry
Direct experience in performing IT vendor audits
Proven and effective communication, and interpersonal skills to influence, resolve conflict and leverage alignment with key stakeholders at all levels organizationally, internally and externally
Ability to articulate advanced CSV concepts to all levels of the organization, as well as external stakeholders and educate on those concepts
Ability to use objective measures to drive decision making and strategy and pragmatically apply appropriate tools to solve critical problems
Ability to influence IT colleagues, illustrate gaps and provide guidance and path forward for GxP systems at Ironwood
Ability to recognize opportunities to lead and teach others as well as play a team member role
Should be active problem solver who has clear understanding of the relationship between individual, functional and corporate goals
Ability to identify and clarify complex problems and constructively provide potential solutions to team
Must have demonstrated managerial leadership skills in developing, providing value-added, fit-for-purpose subject matter expertise in validation
Knowledge of GxPs and ICH Guidance is a must
Advanced degree in technical field preferred

Director, Quality Systems Resume Examples & Samples

Lead and manage activities which drive improvement and ensures all locations meet or exceed Reinhart quality and food safety standards, are operationally efficient, meet third party and customer requirements, and comply with government regulations
As a Certified PCQI, oversee and continuously improve QFS programs, SOP’s and training materials to ensure compliance with FSMA, FSVP, HACCP, USDA, Preventive Controls, Food Defense, etc
Designated interface with regulators regarding recalls, licensing, food safety issues and concerns
Work with locations to create strategies to mitigate audit deficiencies and risks to prevent recurrence
Develop, maintain and continuously improve departmental policies, standard operating procedures, work instructions, templates and other required documents
Establish, conduct and oversee FSQA internal and/or third party GFSI scheme audits of high risk suppliers and co-packers, to ensure FSMA, FDA, and USDA compliance
Train and develop FSQA team members to audit independently and carry out full internal audits successfully
Instill robust corrective action tracking and proactively identify gaps in quality system to minimize food safety and customer quality concerns. Participate in cross functional Supplier and Co-pack selection, approvals and compliance
Support product recalls and withdrawals, including during 24/7 night and weekends
Analyze governmental, supplier and customer account food safety and security initiatives for incorporation into Reinhart operating procedures
Coordinate quality and food safety expectations, compliance activities and quality improvement initiatives with partner groups such as Independent Marketing Alliance (IMA) and Markon Produce
Provide oversight for the successful, aligned implementation of LIMS, and establish a change control process for the future
Provide FSQ guidance regarding special situations (e.g. floods, fire, hurricane, power outages)
Represent company in interactions with customer meetings, sales support requests and trade associations, such as Independent Marketing Alliance (IMA), Markon Produce, National Restaurant Association (NRA), International Food Distributor Association (IFDA), etc
Analyze & negotiate resolution of food safety and quality issues
Develop, support, coordinate and implement customer and sales oriented training related to quality programs and food safety/security programs
Conduct routine, random, and competitive product cuttings to ensure products meet expectations
Oversee clear and concise technical writing of SOP’s, Process Flows, Specifications and Programs
Support Corporate Standards and Quality Assurance teams in regard to specialized knowledge in relation to allergens, product claims, and product labeling
Provide Commercialization and Acquisition support within scope of responsibility
Develop strong talent development plan for the QA function to support growth
Bachelor’s degree required; Food Science or related with foods experience preferred
Minimum of 10 years of work experience in food manufacturing and distribution systems
Certified PCQI with 2+ years of internal auditing experience
Skilled in risk analysis and mitigation, prioritization, problem solving and corrective action
Proven program management experience
Strong interpersonal, verbal and written (including email) communication skills with professional demeanor
Demonstrated success in training and developing quality and food safety personnel
Proven leader with excellent collaboration and teamwork skills, including the ability to nurture a strong food safety culture
This position must pass a post-offer background and drug test
Lean Quality Training with successful applications a plus

Associate Director, Quality Systems Resume Examples & Samples

Author quality system trend reports and develop metric control plans for management review reporting
Establish meaningful thresholds for quality system metrics
Develop or enhance metric control plans for operational review areas including manufacturing supply management, quality system management, and product and process management
Discuss data trends with functional departments, learn special causes and common causes for variation
Teach teams how to interpret data trends and appropriate action plans for out of trend results
Collaborate with cross functional teams to solve problems and analyze data
Facilitate monthly metric review meetings at the commercial manufacturing site
Enhance and develop quality risk management tools and methodologies and apply to the commercial quality system
Facilitate and or lead execution of risk management activities at the commercial site
Facilitate and lead complex investigations, utilize structured approach to root cause analysis and corrective action plan development
Led development of the annual product quality review templates, data analysis and report creation
Compile data, analyze data, draw data driven conclusions and develop risk based action plans through the CAPA system for management review outputs and annual product quality reviews