Senior QA GCP Manager

21 hours ago

Alameda, California, 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 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 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 the approach 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.
Preferred Qualifications
  • Demonstrated knowledge of the drug development process.
  • Demonstrated audit conduct and management experience, particularly in GCP and PV disciplines.
  • 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.

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.

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