Senior Director, GCP/GVP/GLP Quality Assurance

SUMMARY/JOB PURPOSE:

The Senior Director of GCP/GVP/GLP Quality Assurance 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. This leader will integrate Quality throughout the GCP process, audit using a risk-based approach, implement Quality Risk Management (QRM), track and trend key metrics, and ensure clinical data integrity. This individual will also identify and drive continuous improvement, partnering with Product Development, Clinical Development, Clinical Supply Chain, project teams, Medical Affairs, and Regulatory. This person will be a strong partner with internal and external partners to resolve issues for continuous improvement. The Senior Director aligns key QA strategies with business goals and understands the global regulatory compliance landscape.

This leader will represent Quality as the QA Partner (Primary Point of Contact), be speaking One Voice for Quality for Exelixis business stakeholders and represent QA in an outwardly and business-facing capacity, in strategic and decision forums, and triage 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 maintains the GCP/PV/GLP QA programs, policies, and procedures; ensures compliance of the non-clinical and clinical trials to applicable health authority regulations and guidelines.

• Acts as the primary business partner for Product Development and provides 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 of 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:

• Provide direction to other individuals.

• Supervises staff, including hiring, scheduling, and assigning work, reviewing performance, and recommends salary increases, promotions, transfers, demotions, or terminations.

• Leads a cross-functional team if required.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• BS/BA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and a minimum of fifteen (15) years of related experience; or,

• MS/MA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and a minimum of thirteen (13) years of related experience; or,

• PhD in a related discipline and a minimum of twelve (12) years of related experience; or,

• Equivalent combination of education and experience.

Experience:

• Typically requires a minimum of twenty-two (22) years of experience in an applicable industry (biotech, pharmaceutical, or related)

• Typically requires a minimum of ten (10) years of people management at various levels of 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.