GCP/GVP QA Director

About the role

The GCP/GVP QA Director is accountable for Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP) systems and activities, drives compliance and continuous improvement, ensures that Quality is integrated throughout GCP/GVP processes, supports internal/external audits, implements Quality Risk Management (QRM), tracks and trends key metrics, and ensures clinical data integrity.

Responsibilities

• Develops and implements GCP and GVP functional strategy to support cross-functional deliverables to ensure that quality is embedded within all steps of Exelixis clinical research and operations.
• Assists in the management of Exelixis partnerships and collaborations and forges strong relationships.
• Demonstrates a high level of independent quality judgment and acumen, and knowledge and experience with cGCP and understanding of the international regulatory landscape.
• Essential Duties/Responsibilities:
• As QA Partner, responsible for assisting the development of internal processes and systems related to GCP/GVP activities.
• Provides direct support to development and clinical study teams; participates 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.
• Responsible for developing, tracking and managing periodic management reports including key GCP/GVP compliance and QA metrics, as applicable.
• Independently determines approach to complex compliance issues and rapidly escalates reports findings, with recommendations for resolution, and verifies that appropriate CAPAs were implemented and documented.
• Supports, trains internal staff and oversees GCP/GVP consultants, as applicable.
• Implements policies and/or procedures within GCP/GVP QA.
• PARTNERS WITH REGULATORY AFFAIRS, CLINICAL OPERATIONS, TRANSLATIONAL MEDICINE, ETC. REGARDING COMPLIANCE ISSUES, PROVIDES COMPLIANCE GUIDANCE TO ALL AUDITED PARTIES.
• Maintains knowledge of current regulation requirements; informs Clinical Development stakeholders of potential impact on the organization.

Requirements

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.

Qualifications

• 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.

Skills

• 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
• Maintains knowledge of other related disciplines
• Excellent MS Office, Word, Excel and PowerPoint skills