Senior QA GCP Manager

3 weeks ago

King of Prussia, Pennsylvania, United States Exelixis Full time
Job Summary

We are seeking a highly skilled Senior QA GCP Manager to join our team at Exelixis. As a key member of our Quality Assurance team, you will be responsible for assisting in the development, implementation, and maintenance of QA systems and activities supporting GCP and PV operations.

Key Responsibilities
  • Assist in the development of internal processes and systems related to GCP and PV QA activities.
  • Provide direct support to clinical study teams and participate in QA planning and implementation to support study operations.
  • Participate in the development and approval of the CQA audit schedule, including the contracting of PV and GCP audits to contractors and conducting complex audits.
  • Develop, track, and manage periodic management reports, including key Clinical and PV Compliance and QA metrics.
  • Participate in and support various development teams.
  • Manage and/or participate in complex audits and regulatory inspections.
  • Independently determine approaches to complex compliance issues and report findings to management with recommendations for resolution and verify appropriate corrective actions and preventative actions (CAPAs) have been implemented and documented.
  • Support, train staff, and oversee GCP/PV consultants.
  • Implement policies and/or procedures within CQA.
  • Partner with other groups, including Regulatory Affairs, Clinical Operations, Translational Medicine, regarding compliance issues and provide compliance guidance to all audited parties.
  • Maintain knowledge of current regulation requirements and inform Clinical Development stakeholders of potential impact on the organization.
  • Provide support during external audits and regulatory authority inspections.
  • Participate in the development and delivery of GCP training internally.
  • Represent CQA in internal presentations on quality issues, initiatives, and projects.
Requirements
  • BS/BA degree in a related discipline and a minimum of nine years of related experience, or MS/MA degree in a related discipline and a minimum of seven years of related experience, or PhD in a related discipline and a minimum of two years of related experience, or an equivalent combination of education and experience.
  • Typically requires a minimum six to eight (6-8) years of related CQA, GCP, PV experience, and/or combination of experience and education/training.
  • At least 6+ years of progressive related experience.
  • Experience in the biotech or pharmaceutical industry is preferred.
  • Demonstrated knowledge of the drug development process.
  • Demonstrated audit conduct and management experience, particularly in GCP and PV disciplines, is required.
  • Working knowledge of supporting preparation and submission activities, specifically in relation to GCP and PV Quality, for global regulatory filings.
  • Excellent verbal and written communication skills.
  • Ability to influence others as part of a collaborative team and negotiate effective solutions; strong interpersonal and social skills.
  • Uses broad expertise or unique knowledge and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways.
  • Develops technical solutions to complex problems.
  • Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
  • Guides the successful completion of major programs, projects, and/or functions.
  • Interprets, executes, and recommends modifications to company-wide policies and/or divisional programs.
  • Has a complete understanding and wide application of technical principles, theories, concepts, and techniques.
  • Detailed-oriented and committed to precision in the execution of tasks and processes.
  • Has knowledge of other related disciplines.
  • Must be proficient in Word, Excel, PowerPoint, and Visio.
What We Offer

Exelixis offers a comprehensive employee benefits package, including a 401(k) plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays, including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

Equal Opportunity Employer

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.

  • Senior QA GCP Manager

    1 month ago

    King of Prussia, Pennsylvania, United States Exelixis Full time

    Job Title: Senior QA GCP ManagerExelixis is seeking a highly skilled Senior QA GCP Manager to join our team. As a key member of our Quality Assurance department, you will be responsible for assisting in the development, implementation, and maintenance of QA systems and activities supporting GCP and PV operations.Key Responsibilities:Assist in the development...

  • Senior QA GCP Manager

    4 weeks ago

    King of Prussia, Pennsylvania, United States Exelixis Full time

    Job Title: Senior QA GCP ManagerExelixis is seeking a highly skilled Senior QA GCP Manager to join our team. As a key member of our Quality Assurance department, you will be responsible for assisting in the development, implementation, and maintenance of QA systems and activities supporting GCP and PV operations.Key Responsibilities:Assist in the development...

  • Senior QA GCP Manager

    2 weeks ago

    King of Prussia, Pennsylvania, United States Exelixis Full time

    Job Title: Senior QA GCP ManagerExelixis is seeking a highly skilled Senior QA GCP Manager to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest standards of quality in our GCP operations.Key Responsibilities:Develop and implement QA systems and activities supporting GCP and PV...

  • Senior QA GCP Manager

    1 week ago

    King of Prussia, Pennsylvania, United States Exelixis Full time

    Job SummaryWe are seeking a highly skilled Senior QA GCP Manager to join our team at Exelixis. As a key member of our Quality Assurance team, you will be responsible for assisting in the development, implementation, and maintenance of QA systems and activities supporting GCP and PV operations.Key Responsibilities:Assist in the development of internal...

  • Senior QA GCP Manager

    2 weeks ago

    King of Prussia, Pennsylvania, United States Exelixis Full time

    Job Summary:We are seeking a highly skilled Senior QA GCP Manager to join our team at Exelixis. As a key member of our Quality Assurance team, you will be responsible for assisting in the development, implementation, and maintenance of QA systems and activities supporting GCP and PV operations.Key Responsibilities:Assist in the development of internal...

  • Senior QA GCP Manager

    4 days ago

    King of Prussia, Pennsylvania, United States Exelixis Full time

    Job Summary:Exelixis is seeking a highly skilled GCP Quality Assurance Manager to join our team. The successful candidate will be responsible for assisting in the development, implementation, and maintenance of QA systems and activities supporting GCP and PV operations. This role will also involve planning and conducting audits of vendors and associated...

  • Senior Quality Assurance Manager

    1 week ago

    King of Prussia, Pennsylvania, United States Paramount Staffing Full time

    Job DescriptionWe are seeking a highly skilled Senior Quality Assurance Manager to drive our quality assurance strategy and lead a team of QA engineers. The ideal candidate will have a strong background in manual and automated testing, as well as excellent leadership abilities.Key Responsibilities:Design, implement, and maintain a robust QA strategy,...

  • Senior Quality Assurance Manager

    3 weeks ago

    King of Prussia, Pennsylvania, United States Exelixis Full time

    Job Summary:Exelixis is seeking a highly skilled Senior Quality Assurance Manager to join our team. As a key member of our Quality Assurance department, you will be responsible for assisting in the development, implementation, and maintenance of quality systems and activities supporting Good Clinical Practice (GCP) and Pharmacovigilance (PV) operations.Key...

  • Director of Quality Management

    2 weeks ago

    King of Prussia, Pennsylvania, United States PSI CRO Full time

    Join PSI CRO, a dynamic and global company founded in 1995, as we bring together over 2,700 driven, dedicated, and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. **Key Responsibilities:** * Resource Management and Training: Participate in QM resource allocation,...

  • QA Lead

    1 week ago

    King of Prussia, Pennsylvania, United States JobRialto Full time

    Job Summary:We are seeking a seasoned Quality Assurance Lead to spearhead our quality assurance strategy and lead a team of QA engineers at JobRialto. The ideal candidate will ensure efficient test planning, execution, and continuous improvement of testing processes.This role demands a blend of manual and automated testing expertise, strong leadership...

  • Quality Assurance Manager

    1 week ago

    King of Prussia, Pennsylvania, United States CSL Behring Full time

    Job SummaryThe Quality Assurance Manager will be responsible for managing Global CQA activities in the respective regions (Asia-Pacific, Americas, EMEA, Japan) and globally. This role will involve planning, maintenance, and implementation of the assigned Global R&D Quality Audit Program with focus on Clinical Development (from early First in Human to late...

  • Senior Quality Assurance Manager

    1 week ago

    King of Prussia, Pennsylvania, United States Omni Inclusive Full time

    Key Responsibilities:As a Senior Quality Assurance Manager, you will be responsible for leading the testing efforts for our Identity and Access Management (IAM) applications. This includes developing and executing test plans, managing test teams, and ensuring high-quality testing results.Requirements:Strong knowledge of QA processes and testing activities,...

  • Senior Water Project Manager

    1 month ago

    King of Prussia, Pennsylvania, United States Herbert, Rowland & Grubic Full time

    Senior Water Project ManagerHerbert, Rowland & Grubic is seeking a highly skilled Senior Water Project Manager to join our team of talented professionals in Harrisburg, PA. As a Senior Water Project Manager, you will be responsible for managing environmental water/wastewater projects, preparing project designs and reports, and administering construction...

  • Senior Clinical Research Associate

    2 weeks ago

    King of Prussia, Pennsylvania, United States Parexel International Corporation Full time

    Job Title: Senior Clinical Research AssociateAt Parexel International Corporation, we are seeking a highly skilled and experienced Senior Clinical Research Associate to join our team. As a key member of our site management team, you will be responsible for ensuring the successful execution of clinical trials at assigned sites.Key Responsibilities:Build and...

  • CQA Management/Audit Specialist

    4 days ago

    King of Prussia, Pennsylvania, United States BioSpace, Inc. Full time

    Job DetailsThe OpportunityClinical Quality Assurance (CQA) professionals play a vital role in ensuring the integrity and quality of clinical trials. As a CQA Management/Audit Specialist at BioSpace, Inc., you will be responsible for managing global CQA activities in various regions, including Asia-Pacific, Americas, EMEA, and Japan. Your primary focus will...

  • Senior Statistical Programmer

    2 weeks ago

    King of Prussia, Pennsylvania, United States PAREXEL Full time

    Job Summary:The Senior Statistical Programmer will provide technical expertise for the conduct of clinical trials, acting as an internal subject matter expert in specific areas and providing technical support and expert advice. This role will work independently to support various programming activities related to the analysis and reporting of clinical study...

  • Senior Director of R&D Third Party Quality

    4 weeks ago

    King of Prussia, Pennsylvania, United States GSK Full time

    Job SummaryLead the R&D quality management of Third Parties involved in all outsourced manufacturing, analytical and distribution process steps from development to commit to phase III clinical vaccines and medicines.Provide quality leadership to the incoming material suppliers and supplier network for our externally supplied to the R&D GSK manufacturing...

  • Quality Assurance Specialist

    2 months ago

    King of Prussia, Pennsylvania, United States Exelixis Full time

    Job Summary:Exelixis is seeking a highly skilled Senior Quality Assurance Manager to join our team. As a key member of our Quality Assurance department, you will be responsible for assisting in the development, implementation, and maintenance of quality systems and activities supporting Good Clinical Practice (GCP) and Pharmacovigilance (PV) operations.Key...

  • Senior Quality Assurance Specialist

    2 weeks ago

    King of Prussia, Pennsylvania, United States Parexel International Corporation Full time

    We are seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team at Parexel International Corporation. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.Key Responsibilities:Provide guidance and support to our operational...

  • Senior Business Analyst

    4 weeks ago

    King of Prussia, Pennsylvania, United States NTT DATA Full time

    Job Title: Senior Business AnalystJob Summary:We are seeking a highly skilled Senior Business Analyst to join our team in Oaks, Pennsylvania. As a Senior Business Analyst, you will be responsible for participating in daily scrum stand ups, backlog grooming and refinement sessions, sprint planning meetings and sprint review and retrospective meetings. You...