Senior Director, GCP, GVP, GLP QA

SUMMARY/JOB PURPOSE:

The Senior Director, GCP/PV/GLP QA  is accountable and responsible for defining and implementing strategy and leading a team to ensure QA compliance across GCP, PV and GLP functions, systems and activities. Integrates Quality throughout all the GCP process, audits using a risk-based approach, implements Quality Risk Management (QRM), tracks and trends key metrics, and ensures clinical data integrity. Identifies and drives continuous improvement, partnering with Product Development, Clinical Development, Clinical Supply Chain, project teams, Medical Affairs and Regulatory. Strong partner with internal and external partners to resolve issues for continuous improvement. Aligns key QA strategies with business goals and understands the global regulatory compliance landscape.

Represents QA as the QA Partner (Primary Point of Contact), speaking One Voice for Quality, for Exelixis business stakeholders, and represents QA in an outwardly and business-facing capacity, in strategic and decision forums, and triages communication between Exelixis business functions internally or externally and QA, to provide and ensure delivery on company core goals and pipeline deliverables.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Establishes and maintain the GCP/PV/GLP QA programs, policies and procedures; ensure compliance of the non-clinical and clinical trials to applicable health authority regulations and guidelines.

• Act as the primary business partner to Product Development and provide guidance to ensure data integrity and appropriate risk management.

• Partner with Audits and use Quality Risk Management (QRM) to determine which sites to audit, frequency, and track and trend findings to ensure compliant conduct of Exelixis Sponsored clinical trials.

• Participate in inspection management, mock inspections, vendor audits, and Health Authorities inspections.

• Understand and interpret regulatory agency policies and guidances.

• Accountable for QA review of non-clinical and clinical trial documentation, and documents submitted to regulatory agencies.

• Author, review, and approve Quality documents.

• Monitor current and projected quality issues, escalate and drive for rapid resolution on events of significance for Exelixis’ business interests.

• QA Partner for Exelixis business stakeholders, in an outwardly and business-facing capacity, in strategic and decision forums, and triage communication between Exelixis business functions and QA to ensure delivery on company core goals and pipeline deliverables. Develops QA strategy for own area aligned with business needs; manages complex issues, escalates rapidly and drives for resolution.

• Provide guidance, coaching and development to QA Core.

SUPERVISORY RESPONSIBILITIES:

• Leads a team of quality professionals.

• Leads a cross functional team if required

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and a minimum of fifteen years of related experience; or,

• MS/MA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and a minimum of thirteen years of related experience; or,

• PhD in related discipline and a minimum of twelve years of related experience; or,

• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• Typically requires a minimum of 22 years’ experience in applicable industry (biotech, pharmaceutical or related)

• Typically requires a minimum of 10 years of people management at various levels of the management (direct or indirect).

• Demonstrated knowledge of cGxP (GCP, PV, GLP), drug development and applicable Global Regulatory Requirements and regulations.

• Uses broad expertise or unique knowledge and skills to develop company objectives and principles, achieving goals with measurable impact and outcomes.

• Excellent written, oral and presentation communication skills, able to translate complex concepts across all levels of the organization.

• Applies strong analytical thinking to develop technical and/or business solutions to complex problems. Drives for results.

• Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.

• Ensures successful completion of major programs, projects and/or functions.

• Hires strong staff, provid