QA Head Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the qa head 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

K Haag

Kaylee

Haag

596 West Forest

Boston

+1 (555) 125 3026

596 West Forest

Boston

Phone

p +1 (555) 125 3026

Experience Experience

Philadelphia, PA

Head TRD QA India

Philadelphia, PA

Kautzer-Schuppe

Philadelphia, PA

Head TRD QA India

5)Ensure to work with TRD Line Units to provide quality as a competitive ad-vantage
18)Effectively manages the interface between the team and stakeholders in other functions in and outside of TRD and Global Pharma Development
7)Promote a culture of Quality, high performance and trust at the site
13)Works within the global line function leadership team to ensure proper allocation of projects, people and resources, and provides guidance to the project teams
19)Assumes direct people management responsibility for all team associates, 20)Ensures that the most talented associates are hired, trained and developed 21)Achieves a true culture of empowerment and innovation, diversity and inclusion, trust, high performance and continuous improvement mind-set
3)Adequate budget and resource management for all assigned projects according to guidance given by the department
14)Ensures the continuous improvement of processes to maintain high quality standards and operational excellence

New York, NY

Head of QA & RA

New York, NY

Gerlach-Crona

New York, NY

Head of QA & RA

Providing strategic advice to senior management throughout the development of a new product, and post-approval maintenance,
Project managing teams of colleagues involved with the development of new products,
Reviewing company practices and providing advice on changes to systems,
Developing and writing clear arguments and explanations for new product licences and licence renewals,
Liaising with, and making presentations to, regulatory authorities and to senior management,
Working with specialist computer software and resources,
Keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exporting to

present

Phoenix, AZ

Corporate Head of QA-it

Phoenix, AZ

Mann, Johnston and Kshlerin

present

Phoenix, AZ

Corporate Head of QA-it

present

Management of vendors/contractors performing Installation, Operational, and Performance Qualification
Make recommendations for new equipment, system or service to purchase and work with vendor on procurement
Manages the electronic support of various systems of the Quality Department
Provide software/Hardware training to QC personnel
Responsible for the Validation/utilization of software to automate laboratory procedures
Responsible for system efficiency and on-site and remote technical support
Responsible for all aspects of creating, validating and deploying electronic laboratory procedures to the Quality Department. These aspects include installation of instrument connections, method loading, validation activities, and leading the technical relationship between IT and Quality

Education Education

Bachelor’s Degree in Scientific

Seton Hall University

Bachelor’s Degree in Scientific

Skills Skills

Able to lead, influence and coach complex, cross-functional teams
Excellent oral and written communications skills in English
Assess Computerized System networks and summarize the essentials in a format understandable for a variety of stake-holders with very different backgrounds
Ability to work independently and in a team environment
Excellent communication, negotiation and influencing skills
Previous experience or training in Computerized System validation and auditing for the pharmaceutical industry
Experience in working with numerous and diverse stake-holders in a complex matrix environment
Understanding of latest industry, technology, and regulatory trends
Skills and experience in managing multiple concurrent projects in matrix organizations
Experience of managing external suppliers

Create a Resume in Minutes

9 QA Head resume templates

Read our complete resume writing guides

Head, Operations & QA Resume Examples & Samples

Demonstrated leadership ability
Successfully and simultaneously manages multiple transformational change programs
Transformational Business Impact or Very High Business Risk
Uncertain Business Requirements
New & Legacy Technology
Drives/Sets technology direction - E
Manages budget greater than $40MM (systems development, vendors and capital) - E
Deep knowledge of businesses/functions strategies and critical success factors - E
Awareness of marketplace and technology opportunities to help shape business ideas and plans - P
Expert in the application of the Talent management process (recruitment/selection, performance management,
Ability to develop and maintain a network of relationships with key influencers including service partners, peers,
Knowledge of relevant technology - P
Knowledge of IT Standards, Methodologies, CMM and audit requirements - E
General knowledge of factors affecting business - E
BU Specific Strategies & Critical Success Factors - P
Trends in the marketplace/ technology - E
Project Plan development & management - E
Work breakdown structure - E
Task based plans - E
Assumption & risk based plans - E
Base-lining & scheduling, Scheduling methodology (CPM, GERT, PERT) - E
Waterfall and iterative methodologies - E
Project metrics gathering, reporting, analysis - E
Program Plan and metrics - E
Program Governance - E
Risk Assessment & quantification methodologies - E
Issues escalation and resolution - E
Facilitation Skills - E
Scope change management - E
Cost/Benefit Analysis & alternatives identification - E
Budgeting, project costs management - E
Quality Controls - E
Procurement - E
Communication management & plans - E
RBC HR philosophy, principles, direction, policies & guidelines - P
Talent Management process (recruitment/selection, performance management, performance development/coaching,

Regional Head of, QA Resume Examples & Samples

Liaison closely with the Global Head of iQA to ensure that the respective iQA Americas team is operating in accordance to internal guidance and procedures
Expansion of iQA in accordance with BMO country expansion/deployment for Americas
Ensures a consistent iQA Framework, Methodology, Tools and Reporting in a consistent fashion within the Americas of which iQA is established
Generate iQA MI/reporting, and ensure special projects are completed accurately within the given time frames
Ensure iQA Team Leads liaison closely with the Learning & Development (L&D) resources to make certain that quality results are captured as part of the L&D needs assessment to continuously build/leverage training program in efforts to improve the quality of KYC profiles
Ensure appropriate and timely response to internal/external audit inquiries as it pertains to KYC Profiles, including quality review results
Responsible for the iQA rollout and presence into non-BMO/KYC expansion sites
This role reports functionally to the Global Head of iQA
Manage, through the iQA Leads, the Independent Quality Assurance (“iQA”) Teams ensuring that KYC profiles are in accordance with AML Regulations and HSBC policies and procedures
Directly manage the Americas iQA team; ensuring that KYC profiles are in accordance with AML Regulations and HSBC policies and procedures
Critical external interface with GBM stakeholders across Global Banking and Markets (i.e., KYCS Senior/ Midde Management and Production Teams, Compliance, and Business
Support and execute the roll out of Global Standards and the ‘readiness’ of new GBM On-boarding sites, from a quality assurance perspective
Minimum 5 years KYC experience
Minimum 2 years KYC quality assurance experience for a large International Financial institution with experience of due diligence of Financial Institutions, Non Bank Financial Institutions, Hedge Funds, Funds, SPVs and major Corporate clients
Minimum 3 years of client on-boarding experience
Minimum 2 year of Management/Leadership
Minimum 2 years of project management
Involvement in audit of KYC function (internal/external)
Management Information reporting (KPI/KRI, exceptions reporting)
System User Acceptance Testing experience
Strong PowerPoint/presentation skills
AML qualification and or post graduate Compliance degree is an advantage
CAMS certification preferable
Microsoft Word, Excel. Power Point and Access a plus

O&T Latam Business Acceptance Head Global Operations QA Resume Examples & Samples

Minimum 10 years experience in Operations or Technology function, including project & test management, SDLC/agile process and especially on end to end business testing
Strong operation and product knowledge in Consumer Banking system. Experience in Global common/Rainbow rollouts would be an added advantage
Analytical, automation and problem solving skills are required, including a thorough understanding of operations and business products, and translate them into end to end testing approach
Strong collaborative skills in leveraging and working in partnership with business and vendor teams, in ensuring all teams arrive at common objectives
Experience in QA management to deliver projects within schedule and cost successfully
Managing teams across geographic locations to implement centralized business testing strategy
Ability to form strong partnership with Country Business management team in ensuring delivery as per Global Common program needs
Good presentation skills and able to lead and influence teams to common objectives
A flexible approach to work with the ability to accept and champion change
Ability to work to tight deadlines and to prioritize conflicting and changing priorities

Head of R&D QA Clinical & Medical Program Compliance Resume Examples & Samples

30%: Creation and Execution of Program Audit Plan
10%: Regulatory Agency Support
Bachelor’s degree in a life science required; Masters Degree in management or scientific discipline a plus
At least 10 years of pharmaceutical experience
Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance, GCP auditing and at least 7 years of direct management experience

Global Head of QA Resume Examples & Samples

Regarded as the expert level advisor both within and outside the organization
Develop mature yet practical quality assurance and testing framework and processes to support product developments
Select/consolidate standard set of tools to maximize the productivity and portability
Drive seamless integration of unit/manual/automation/performance for various product layers/components to have well-coordinated executions
Analytical driven decision making to align with product owners on investment/speed to market/quality
Prior, significant experiences with financial services industry
Consulting experiences with well-known organizations
Overseas working experiences in a senior managerial capacity

Head of QA Resume Examples & Samples

Maintain high standards within the quality assurance team by coaching, mentoring, and disciplining employees through planning, monitoring, and reviewing performance
Maintain cost objectives by preparing the quality assurance forecasts with resourcing and expenditure scheduling; utilising available budget, analysing variances and initiating corrective action
Technical Understanding
Development Methodologies and Procedures
Analysing Information
Behavioural Testing

Country QA Head, Novartis, Sweden Resume Examples & Samples

Lead the local Swedish QA organization to ensure implementation, maintenance and continuous upgrading of the Quality System to drive compliance of all cGxP processes with local regulatory requirements and the Novartis Quality Manual
Ensure quality governance and quality planning in Sweden through the establishment and implementation of the annual Quality Plan, appropriate KQIs, and Quality Risk Assessments
Contribute from the Swedish perspective to Nordic Quality Review Board
Ensure GCP and Good Pharmacovigilance Practice oversight and quality & compliance of Development and Medical Affairs (MA) projects, products and programs (Phase I through Phase IV) in Sweden
Ensure efficient information flow and effective communication of all relevant quality matters from Sweden to the Nordic and Global QA organization and vice-versa including issue escalation
Ensure that all commercial drug products and IMPs are released in accordance with the registered specifications and are released to the market in accordance with regulations
Ensure country readiness for all GxP regulatory inspections. Ensure management of external inspections and audits
Ensure that local audits and self-inspections are performed in Sweden and at 3rd parties, as appropriate and timely implementation of appropriate and effective corrective and preventive actions
Degree in Life Sciences or related fields
Min. 5 – 6 years experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, clinical development or production or a directly related area
Qualified Person, QP qualification can be considered as advantage

Global Head Dev QA Chief Medical Office & Patient Safety Resume Examples & Samples

Aligning closely with our business partners, drive global quality oversight and governance of patient focused activities, including Patient Safety, Pharmacovigilance (PV), Device Vigilance, Ethical, Regulatory and Reputational issues covering Novartis Enterprise, including Novartis Divisions and all countries
Drive quality oversight and governance of the activities of the Global Drug Development (GDD) Chief Medical Office, including the Global Governance Office for applicable Novartis commercial medical functions to ensure compliance with regulatory requirements and harmonized internal standards are in place for global, regional and local patient focused activities, ensuring maintenance of a comprehensive escalation process for the Product Stewardship Board, the Global Governance Office for applicable Novartis commercial medical functions
Provide Quality leadership and governance for the Global Governance Office to ensure standards are in place for all regulatory obligations GXP/Vigilance and industry standards related to global PV, Device Vigilance, patient focused commercial and medical activities, including non-registration studies (IITs, NIS, Local Phase IV), MAP, research grants, products internet websites and external mobile apps patient support programs/market research, educational materials
Maintain oversight on the structures, processes and outcomes of the Novartis Enterprise PV/Device Vigilance quality system and the release of the Novartis Pharmacovigilance System Master File (PSMF) to ensure compliance with regulatory requirements, internal standards and the protection of patients for the entire Novartis product portfolio and covering the full product life cycle
Ensure effective global PV/Device Vigilance and CMO vendor quality oversight and management is in place
Contribute to the quality management cycle including authoring annually PV/Device Vigilance and CMO components of the GDD Quality Plan
Drive quality performance of the Novartis PV and Device Vigilance Systems to ensure tasks and responsibilities required under global Pharmacovigilance and Device Vigilance regulations are fulfilled, including monitoring safety of Novartis-authorized products and detecting changes to their risk-benefit balance
Ensure continued inspection readiness through coordination, preparation, facilitation and follow up of global and local applicable regulatory inspections
At least 10 years of Pharmaceutical industry experience with at least 5 years of PV, Quality Management and/or GXP Regulatory experience demonstrating increasing levels of responsibility
At least 3 years global team management experience or equivalent
Thorough and extensive knowledge of international regulations including FDA/EU PV, ICH, new drug regulations, other key HA guidance’s, and current industry practice
Prior experience with coordination of HA inspections
Ability to reconcile worldwide safety compliance requirements with business goals
Experience and ability to work in matrix cross-functional environments
Effective leadership skills, experience managing associates across functional and geographical boundaries as well being part of a cross-functional team demonstrating the ability to influence and create alignment across multiple functional areas
Excellent negotiation and presentation skills

Global Head Biosimilar Clinical QA Resume Examples & Samples

Ensure areas needing quality and process improvements are proactively addressed with Sandoz; this includes but not limited to ensuring that CAPAs, Audits, and remediation activities are effectively aligned with the goals of the business and regulatory expectations; Ensure knowledge transfer of Biosimilar GCP learnings to Sandoz Small- molecules as necessary
Building and leading a global team of high-performing quality
Responsible to re-asses the existing structure of QA teams and implement changes wherever necessary to ensure efficiency in operating structure and adequate succession in place
Ensure proactive representation of Quality professionals at strategic project teams and ensure proper cross-functional learnings and interactions
Support the Global and Regional CPO teams with Quality input and oversight for the execution of clinical trials under their responsibility
Support through open and effective communication and business partnering the cross-functional implementation of the Vision and Mission of Global Drug Development QA. Drive a culture of solution oriented and evidence based mindset with openness for innovative ways of working and new technologies
Manage the relevant budget and headcount including

QA Section Head / Manager Resume Examples & Samples

Coordinate the CQA, IQA, Document Control and ISO9000 requirements and compliance
Create and implement monitoring tools for the accurate measurement of quality levels
Drive quality improvement effort
Interface with engineering and production departments to help develop process improvement plans
Report quality levels to all personnel with recommendations for improvement plans
Take care of customer quality feedback
Responsible for supervising the QA engineers, technician and inspectors or others in performing the functions/responsibilities listed above

Dir Head of QA Systems Resume Examples & Samples

Provides leadership and management for QA Systems department, in accordance to CSL management principles
Degree in natural sciences (Pharmacy, Chemistry, Biology, Biochemistry) or medicine or comparable education
Several years of experience in the pharmaceutical industry and the Quality / GMP areas including sound understanding of GMP systems and principles
Experience with regulatory authorities and international inspections
Experience in project management and business/ QA systems
Strong leadership skills (e.g. builds effective teams, develops talent, directs work, drives engagement, cultivates innovation, ensures accountability, interpersonal savvy, communicates effectively, manages ambiguity)
Ability to drive results and optimize work processes
Situational adaptability and organizational and cross-cultural agility
Assertiveness, managerial courage and conflict management skills
Demonstrates self-awareness and self-development
Very good written and verbal communication skills in German and English

Group Head of QA International Resume Examples & Samples

Oversee all QA (Quality Assurance) activities, procedures and output by guiding and supporting the School in quality enhancement, advising on the preparation of relevant documents before the start of the academic year for academics and students etc…
Liaise with School departments to facilitate the smooth planning, organisation and overview of academic activities before and where necessary during the Academic Year
Prepare and organise relevant education committees, internal examiners’s visit and tutor/PL meetings throughout the year
Arrange for minutes to be taken as appropriate, and ensure that Headquarters IMID Department is promptly informed of any activities out of control, ensuring that necessary follow-up actions are undertaken
Liaise on a regular bases with the Academic teams of the Schools (Director of Education, Programme Leaders, Academic Service Department) to advise on the coordination and organisation of academic and School related activities
Lead periodic meetings/visits and activities related to QA in the Schools required by IM Headquarters
Work co-operatively and communicate effectively with all departments in the Schools
Undertake other reasonable and related duties, which may arise due to the nature and character of the post
Regularly liaising with HQ Milan in relation to academic QA activities
Bachelors Degree; Masters Degree is desirable
Previous experience working in a similar role in the academic sector
Ability to prioritise own workload and co-ordinate tasks to meet deadlines
Availability to make international travel
IT literacy
Knowledge of Fashion & Design academia
French, Professional working proficiency
Italian, Native or bilingual proficiency

Corporate Head of QA-it Resume Examples & Samples

Ensures the timely release of newly validated / qualified Quality instruments
Manages the electronic support of various systems of the Quality Department
Responsible for all aspects of creating, validating and deploying electronic laboratory procedures to the Quality Department. These aspects include installation of instrument connections, method loading, validation activities, and leading the technical relationship between IT and Quality
Responsible for the Validation/utilization of software to automate laboratory procedures
System Administration of QC Applications including Empower (future NuGeneses, LIMS, etc.)
Responsible for system efficiency and on-site and remote technical support
Perform backup operations, ensuring all required file systems and system data are successfully backed up to the appropriate media, recovery tapes or disks are created and media is recycled and sent off site as necessary
Repair and recover from hardware or software failures. Coordinate and communicate with impacted constituencies
Make recommendations for new equipment, system or service to purchase and work with vendor on procurement
Management of vendors/contractors performing Installation, Operational, and Performance Qualification
Assess proposed changes to instrumentation and equipment to determine the impact upon the qualification status of the equipment to determine additional needs for validation
Review and post approval of qualification protocols/summary reports for Quality Systems
Critical QA review of Software validation protocols and reports to meet Part 11 requirements for CFR review
Prepare, review and update Software/Hardware Qualification Documents, Change Controls, Corporate Policies, Guidelines, SOP's , etc
Provide software/Hardware training to QC personnel
Minimum of a Bachelor Degree in a related field
Minimum of 10 years of general electronic Quality Systems Management in regulated companies within cGMP environment(s)

Patient Safety QA Regional Head Resume Examples & Samples

Support the regional and country Global Development Quality management cycle through development, execution and accountability for deliverables of the global Pharmacovigilance Quality Plan (QP). Coordinate execution of the QP with relevance to applicable regional and country patient safety and PV relevant functions and report the status to applicable Global CMO and Patient Safety QA team
Establish and monitor indicators that relate to the performance, compliance and quality of regional and country pharmacovigilance systems in line with indicators defined by Global CMO and Patient Safety QA team; Promptly communicate regional and country compliance issues to Global CMO and Patient Safety QA management
Proactively propose potential quality improvement measures and develop strategies aimed at simplifying processes and improving quality of outputs while ensuring compliance with regulatory requirements; share best practice within and across regions. Lead regional initiatives focused on quality improvement and compliance, provide ongoing project support and governance, as assigned
Support Global CMO Patient Safety QA team in the execution of Pharmacovigilance Quality Risk Assessments (QRA) to identify and mitigate regional and country PV risks
Ensure a constant state of regional and country inspection readiness. In line with Global CMO Patient Safety QA team, prepare for, facilitate and lead logistics for Health Authority (HA) Pharmacovigilance inspections, assess results of pre-inspection activities and HA inspection findings in terms of associated risks and communicate to management. Align with CMO and PS team and review corrective and preventive (CAPA) plan to ensure quality, consistency and appropriateness of commitments. Monitor status of CAPAs to ensure they are completed, appropriately documented and sustainable
Drive facilitation and follow-up of PV audits and assist with development of robust and sustainable CAPAs. Monitor the status of CAPAs to ensure they are completed, appropriately documented and sustainable
Support CMO and Patient Safety and other business partners with compliance and deviation investigations and ensure timely escalation to management; provide assistance in the remediation of PV system issues; ensure follow-up and monitoring of completeness of CAPAs in alignment with Global CMO Patient Safety QA team
Oversee definition of self-inspection plans to regional and country pharmacovigilance pro-cesses as well as their execution
Identify regional and local training needs and coordinate/facilitate implementation of training programs that meet the needs of business partners and improve overall quality and compliance
Oversee regional and country monitoring process and compliance status of safety labeling implementation updates as required in Novartis procedures and local legislation
Deputize for Global Head CMO and Patient Safety QA, Regions and Countries or other team member as required
Excellent written and verbal English communication skills; fluency in a second language a plus
Five plus years quality/ PV/ clinical/ regulatory affairs/ pharmaceutical industry/ health authority experience
GCP/PV/GMP auditing or inspection experience and Heath Authority interactions a plus
Experience in PV in a country organization and global quality support to stakeholders in country organizations a plus
Quality mindset and excellent quality and compliance leadership and facilitation skills
Ability to lead teams and operate successfully in various team capacities and diverse cultural environments
Ability to deputize for the Global Head CMO Patient Safety QA Regions and Countries as needed

Head TRD QA India Resume Examples & Samples

4)Ensure all TRD projects have resources for Quality oversight and meet the Quali-ty deliverables
5)Ensure to work with TRD Line Units to provide quality as a competitive ad-vantage
6)Ensure all the associates in the group are properly trained for their assigned task
7)Promote a culture of Quality, high performance and trust at the site
8)Ensure that talented associates in the industry are hired, developed and retained
9)Ensures or supports that budget targets are maintained
10)Contributes to definition and implementation of the global QA strategy
11)Support timely and high quality preparation of analytical documents for regulatory submissions
12)Ensures best-in-class partnership with third party vendors and service providers
13)Works within the global line function leadership team to ensure proper allocation of projects, people and resources, and provides guidance to the project teams
14)Ensures the continuous improvement of processes to maintain high quality standards and operational excellence
15)Ensures best practice sharing and knowledge exchange within the global line function,
16)Ensures compliance to all relevant standards (e.g. HSE, GMP, ISEC). Ensures that all solutions and products are delivered in compliance with all relevant corporate and legal guidelines and quality requirements
17)Acts as member of the global line function leadership team and ensure proper communication of all relevant topics
18)Effectively manages the interface between the team and stakeholders in other functions in and outside of TRD and Global Pharma Development
19)Assumes direct people management responsibility for all team associates, 20)Ensures that the most talented associates are hired, trained and developed 21)Achieves a true culture of empowerment and innovation, diversity and inclusion, trust, high performance and continuous improvement mind-set
1)Achieve key milestones and objectives of Global TRD QA (projects, technology and compliance)
2)Achieve or contribute to budget and productivity goals
3)Adequate budget and resource management for all assigned projects according to guidance given by the department
4)Customer feedback and satisfaction
5)Contribute to achievement of Department key milestones and objectives
6)Build the talent pipeline
7)Strictly adhere to Novartis standards, particularly quality, ethics, health, safety and environment (HSE), and information sharing and security
8)Timely availability, accuracy and completeness of key-source documents and regulatory documents, as appropriate
Minimum of 5 years of relevant experience; minimum of 3 years in a leadership or people management position with successful performance and track record in the role of line/people man-ager in TRD, or a related industrial area (e.g. TechOps)
Experienced leader of global teams with proven track record. 3. Proven track record of successfully managing interfaces to other functions

Head of QA, Bioscience Aseptic Operations Resume Examples & Samples

Directs staff of QA media operations specialists that review and approve device master records, batch records, testing, and aseptic operations. Oversees batch release. Develops and plans strategy and departmental goals, establishes timelines and monitors progress and completion
Provides oversight of aseptic operations including managing QA on the floor team to observe aseptic processing, including media fills to meet US and international aseptic processing requirements (FDA Sterile Product Aseptic Processing Guidance and Eudralex, Annex 1,”Sterile Medicinal Drug Products”, ISO 13408 and 21CFR820). Assesses facility and quality systems’ state of compliance with internal requirements and appropriate regulations, and participates in the development of action plans to correct deficiencies and improve quality processes
Provides direction for complex deviations and complaint investigations; Managing media deviations, CAPAs and Complaint handling and ensuring that quality related deviations, complaints are escalated, investigated and resolved
Leads or supports regulatory or client audits as Aseptic Media subject matter expert
Develops and approves cGMP documents including, but not limited to, SOPs, batch records and specifications. Ensures process is efficient
At least 10 years of GMP experience in biologics manufacturing or equivalent including at least 7 years management experience with at least 5 years in a QA supervisory or management role. Working knowledge of cell culture starting materials and aseptic processing experience required
Experience with oversight of aseptic processing and the associated international aseptic processing regulations and medical device regulations
GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing; ISO 9001:2015, 13485 and Part 11 compliance knowledge preferred. Working Knowledge of endotoxin testing required

Head of Shared Services & QA, T&L IT Resume Examples & Samples

The operating system which enables IT SOE success
QA of End to End IT SOE Processes
Process Tool Set and End to End Process owner
Financial Operations, Reporting, KPI Scorecard
IT Operations and Engineering Transformation Roadmap
Chief of Staff for IT SOE activities
Establish the Run Book of Operations and Modus Operandi for IT SOE
Lead across the Maersk IT SOE function to matrix all of the required functions such that we establish an operating process which works for Maersk IT SOE, our customers, and for our employees
Drive a climate of operational and organisational excellence in IT SOE
Cooperate closely with the Application Development Shared Services function and the OCIO to ensure operating alignment and consistency across Maersk Line T&L IT
Contribute to the Global IT Leadership Team agenda to ensure that we deliver on our mission to be a trusted IT Delivery Partner
Experienced in each of the IT Operations, Engineering and Support Disciplines at scale
ITIL
Quality Assurance of large scale processes
Process Improvement

Head of QA & RA Resume Examples & Samples

Ensuring that a company's products comply with the regulations of the MHRA
Keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exporting to
Collecting, collating and evaluating scientific data that has been researched by colleagues,
Developing and writing clear arguments and explanations for new product licences and licence renewals,
Monitoring and setting timelines for licence variations and renewal approvals
Working with specialist computer software and resources,
Advising cross departments, scientists and manufacturers on regulatory requirements
Providing strategic advice to senior management throughout the development of a new product, and post-approval maintenance,
Project managing teams of colleagues involved with the development of new products,
Undertaking and managing regulatory inspections,
Reviewing company practices and providing advice on changes to systems,
Liaising with, and making presentations to, regulatory authorities and to senior management,
Negotiating with regulatory authorities for marketing authorisation
Demonstrated leadership, management of team including motivating
Strong negotiation skills, proven interaction and collaboration with competent agencies (MHRA/HPRA/DOH/Home Office)
Extensive UK/ IE Affiliate RA knowledge (at least 10+ years),
Educated to degree in life science discipline,
Work across multi-disciplinary teams/ departments (e.g. of collaboration)
Confident and competent written and oral presentation skills
Excellent understanding of the EU/national legislation governing the approval of products
Possess higher second degree (MSc/PhD) in life sciences
Member of TOPRA and other recognised technical professional bodies
Considerable understanding of Regulatory Environment
Knowledge of OTC, FMCG products

Pune Head-equities QA & Asia QA Head-cash Equities Resume Examples & Samples

Build vision and mission for self and the QA organization in Pune
Build a culture of ownership and deliveries in the teams
Help build strong career path for employees in the organization
Manages large QA organization in Pune Provides technical oversight across systems and applications; leverages skills across multiple apps development and QA areas Reviews and analyzes proposed technical solutions for projects
Contributes to formulation of strategies for apps QA and other functional areas Evaluates subordinates' performance and makes decisions on pay increases, hiring, terminations and other personnel actions
Applies in-depth understanding of concepts and procedures within QA area and basic knowledge of other areas like development/production support to resolve issues that have impact beyond own area
Full Software Development Lifecycle Customer interfacing - understand customer requirements, propose technical solutions
Demonstrates a comprehensive understanding of how areas of apps development and QA collectively integrate to contribute to achieving business goals; requires advanced industry knowledge
Requirement gathering and understanding, effort estimation, technical design, project planning and monitoring
Provides evaluative judgment based on analysis of factual information in complicated and unique situations
Deliver high quality , innovative and cost effective service to our business/client/regulators/stakeholders
Must have and good to have explicitly
15+ Years of project experience as
Practitioner of Agile practices
People management, motivate, inspire a large organization
Strong stake Holder management
Strong Investment Banking/financial domain experience
Bachelor’s degree/BTech/ME/MTech (in computers, information technology or engineering)
Ability to work as part of team and independently
Interpersonal skills to interact with team members and clients
Candidate should be willing to work extended hours in order to interact with global partners/teams or as per project demand

Head Digital Development & Transformation QA Resume Examples & Samples

Lead a team of Digital Development (DD) QA experts providing quality and compliance oversight over the transition from the current, traditional Clinical Trial Process into a future, fully electronic and paperless environment
Provide QA oversight to the capture, codification and change processes relevant to the scaled adoption of new technologies
Accountable for the quality and compliance of all QMS relevant process changes required to make Novartis ready for a paperless future and full end-to-end e-Data Integrity
Act as e-technology QA consultant and trainer for the appropriate Business and QA peers and colleagues. Provides training content input to relevant e-data integrity initiatives
Actively contribute to a long term negotiation strategy with all key global Health Authorities and external e-Clinical Organizations, in collaboration with the appropriate Novartis business organizations. Interact directly with Global Health Authorities to promote understanding of Digital Development strategy and to resolve potential regulatory roadblocks
Lead a team of Digital Development QA experts acting as SMEs for all e-technology, e-Source vendor evaluations and provides Quality oversight for existing, e-Technology vendors already used in pilot studies and beyond
Capture, codify and change processes relevant to the scaled adoption of new technologies, including definition of a technology transfer process (‘graduation’) to Line Functions, business case format, and benefits quantification/tracking
At as Key Point of Contact for DD, but also with DRA and other relevant GDO functions like External Dev Operations (EDO), demonstrating and presenting the quality and compliance requirements as needed in order to equip the business organizations with the knowledge that will enable compliance and adoption of new technologies in trials
Establishes a strong relationship with peer QA organizations including but not limited to BDM QA, CSV/e-data integrity QA and Vendor QA
Develop and draft process and planning content as needed, including trial data workflow for inclusion in quality artifacts
Drive and guide Clinical Study Teams on process and necessary lead times. Ensure all e-technology-enabled trials are compliant to internal process, are fully supportive of data integrity and in line with the current, worldwide global HA requirements
Raises contentious issues in a manner that drives resolution, and enables others to do the same
Minimum 10 years of experience in the pharmaceutical industry, in addition a minimum of 2 years in QA, IT, programming or validation
Previous experience or training in Computerized System validation and auditing for the pharmaceutical industry
Understanding of latest industry, technology, and regulatory trends
Assess Computerized System networks and summarize the essentials in a format understandable for a variety of stake-holders with very different backgrounds
Experience in working with numerous and diverse stake-holders in a complex matrix environment
Excellent communication, negotiation and influencing skills
Able to lead, influence and coach complex, cross-functional teams
Excellent oral and written communications skills in English
Skills and experience in managing multiple concurrent projects in matrix organizations
Experience of managing external suppliers

Head of QA Resume Examples & Samples

Deliver : Directs QMS activities to ensure continual compliance of the Site Business Quality Management System in accordance with J&J Enterprise One Quality System, associated Sector standard, and local government regulatory requirements
Connect: As the Management Representative, engages Management and relevant Leadership Team in Quality Reviews and Escalation based on appropriate analytics, tools and reports. Identifies and sponsors initiatives for improvement of opportunity areas and proactively navigate legal changes that may significantly impact the business
Shape: In collaboration with business function/management, develop and implement strategies through integration of early risk evaluation, mitigation and development of compliant solutions to identified growth opportunities. Oversees overall development of local organization in terms of Quality and Compliance objectives
Lead: Establishes robust process in product labeling and product release. Ensures thorough investigation, comprehensive risk assessment and flawless execution of actions in relation to non‐conformances, deviations, CAPA, change management and Field Actions. Oversees timely product quality complaints and adverse event reporting and resolutions
Confers with Management in preparation, formulating and maintaining organization budget and resources

Regional QA Head Resume Examples & Samples

Drive together with the Regional Commercial Leadership Team, Country Heads and the Country Quality units, the implementation of a consistent quality culture and quality organization across the Region and Countries
Lead and influence Quality Culture at the country level and at Regional Commercial Leadership Team
Lead Regional Country Quality Review at Regional Commercial Leadership Team meetings
Drive the implementation of the required actions
Deliver proper management of products throughout product lifecycle (launch of new products, market release, CAPAs, deviations, recalls, etc.)
Lead the adoption and maintenance of applicable Quality Standards and governance processes through the implementation of the Novartis Quality Manual and Policies. Liaise effectively across Alcon organization and Novartis Country Quality organization to ensure that global processes are adequately implemented and sustained in the Countries
Ensure implementation of adequate training within countries for all GXP activities by supporting training activities
Ensure development of talent within the regional and local Country Quality units
Demonstrated experience of successfully leading an organization or project of high impact
Significant Quality Assurance experience and involvement in a related regulated industry; broad understanding of global expectations of Health Authorities in the GxP regulated area
Significant experience within people leadership in the medical device or pharmaceutical industry, people management experience in a matrix environment
Exposure to manufacturing operations and /or quality assurance, country organizations or commercial operations
Ability to influence and inspire the QA and commercial teams
Priority setting against a wide range of strategic and tactical activities