GCP/GVP QA Director

Exelixis•Alameda, CA

1d•Onsite

About The Position

The GCP/GVP QA Director is responsible for Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP) systems and activities, ensuring compliance and continuous improvement. This role integrates Quality throughout GCP/GVP processes, supports internal/external audits, implements Quality Risk Management (QRM), tracks key metrics, and ensures clinical data integrity. The Director develops and implements GCP and GVP functional strategy to support cross-functional deliverables, embedding quality within all steps of Exelixis clinical research and operations. The position also involves assisting in the management of Exelixis partnerships and collaborations, forging strong relationships, and demonstrating independent quality judgment and acumen with knowledge of cGCP and international regulatory landscapes.

Requirements

BS/BA degree in related discipline and a minimum of 13 years of related experience; or, MS/MA degree in related discipline and a minimum of 11 years of related experience; or, PhD in related discipline and a minimum of 8 years of related experience; or, Equivalent combination of education and experience.
Minimum of 13 years of relevant experience in pharmaceutical/biotech.
Minimum of 8 years GCP/GVP/Drug Safety Quality Assurance experience.
Experience in the development of business strategies, metrics, and continuous improvements.
Demonstrated knowledge of the drug development processes.
Demonstrated GCP/GVP audit conduct and management experience.
Working knowledge of supporting GCP/GVP preparation and submission activities for global regulatory filings.
Excellent verbal, written, and presentation communication skills, able to translate complex concepts across all levels of the organization.
Ability to influence others as part of a collaborative team and negotiate feasible solutions; strong interpersonal and social skills.
Uses broad expertise or unique knowledge and skills to contribute to meeting company core objectives and principles, and to achieve goals in creative and effective ways.
Develops technical solutions to complex problems.
Deep knowledge and understanding of drug development process, Global Regulatory Requirements and regulations related to GxP/ GVP.
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 companywide policies and/or divisional programs.
Has complete understanding and wide application of technical principles, theories, concepts and techniques.
Detailed oriented and committed to precision in execution of tasks and processes.
Has knowledge of other related disciplines.
Excellent MS Office, Word, Excel and PowerPoint skills.

Responsibilities

Assist the development of internal processes and systems related to GCP/GVP activities as a QA Partner.
Provide direct support to development and clinical study teams.
Participate in QA planning and implementation to support study operations, development and approval of Clinical audit schedule including contracting GCP/GVP audits to contractors, conducting audits, and regulatory inspections.
Develop, track and manage periodic management reports including key GCP/GVP compliance and QA metrics, as applicable.
Independently determine approach to complex compliance issues and rapidly escalate reports findings, with recommendations for resolution, and verify that appropriate CAPAs were implemented and documented.
Support, train internal staff and oversee GCP/GVP consultants, as applicable.
Implement policies and/or procedures within GCP/GVP QA.
Partner with Regulatory Affairs, Clinical Operations, Translational Medicine, etc. regarding compliance issues, provide compliance guidance to all audited parties.
Maintain knowledge of current regulation requirements; inform Clinical Development stakeholders of potential impact on the organization.