Rapidly growing drug development company seeks a Director of QA and GCP Compliance to lead quality activities at the company’s site in the San Francisco Bay Area. The Director of GCP, QA and Compliance will “own” the site’s quality program and should have a strong background in good clinical practices, in clinical quality and clinical operations. This is a remote role with in-office work as needed for meetings.
- Bachelor’s degree in a relevant life sciences discipline, advanced degree preferred.
- 10+ years’ experience in the pharmaceutical industry or with contract research organizations in a clinical quality assurance and clinical operations role
- Strong working experience and knowledge of Good Clinical Practices (GCP) and ICH.
- Extensive GCP auditing experience
- Strong presentation skills
- A track record of leadership for developing and implementing key strategic issues and significant QA policies, practices and processes
- Demonstrated decision making experience resolving complex problems, providing sound compliance advice and direction
- Must have high level of attention to detail and must have ability to deal professionally with team members, clients and investigational sites
- High level understanding of FDA Guidelines, ICH Guidelines, GCP, NDA, IND and other pharmaceutical and drug development regulations
- Excellent leadership communications skills, oral, written, electron and presentation.
- Fluency in spoken and written Chinese preferred
Responsibilities of the Director QA and GCP Compliance:
- Develop, implement, and maintain a GCP / ICH compliant quality assurance program
- Develop and maintain SOPs, including review, and coordination initiation and or revision of procedures and policies to ensure compliance with changing regulations and guidelines
- In coordination with clinical development and clinical operations teams ensuring adherence to GCP compliance through all stages of clinical trial including, core study execution documents, clinical trial sponsor oversight, issue escalation, internal and external audit support
- Manage the GCP audit program including vendor oversight, TMF and site audits, and CAPAs.
- Serve as point of contact for sponsor or regulatory audits as required