Responsibilities
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. 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.
SUPERVISORY RESPONSIBILITIES:
- No supervisory responsibilities.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
- 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.
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.
Knowledge, Skills and Abilities:
- 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.
Work Environment/Physical Demands:
Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
- This position is onsite
- Travel as required (15-20%)
WORKING CONDITIONS:
Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
