Role OverviewWe are seeking a Senior Director Quality GCP to provide strategic oversight of phase-appropriate Quality GCP and GCLP activities, including GCP quality oversight of ongoing quality activities supporting active pre-clinical and clinical programs. This role requires an 75% on-site presence.
What You Will Do
Primary GCP Quality contact for identified vendors and investigator sites supporting clinical programs, author key GCP quality SOPs, develop a risk-based GCP compliance program, and provide GCP and other GxP training.
Why It Might Be a Fit
You will work closely with industry leaders in Boston and Basel, lead and participate in inspection readiness activities for regulatory inspections, and interface with internal departments and external vendors on a variety of technical/quality subjects.
Requirements
- BS Degree in Chemistry, Pharmacy, Biology or a related life science, or a combination of a BS Degree with relevant Quality and Technical experience
- Minimum of 16 years of experience within the pharmaceutical or biopharmaceutical industry, with development experience and exposure to commercial operations
- Knowledge and experience of clinical and commercial systems supporting GCP compliance with US and global regulations (FDA, EMA, ICH, MHRA, etc.)
- Ability to provide solution-minded approach and flexibility to emerging challenges
- Ability to appropriately balance priorities plus multi-task against competing priorities
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