Associate Director / Director – GCP Quality

Responsibilities

• Primary GCP Quality contact for identified vendors and investigator sites supporting clinical programs as well as other GCP quality events (e.g., potential serious breach assessments, CAPAs)
• Author key GCP quality SOPs and key reviewer for other quality (GxP) procedures
• Develop a risk-based GCP compliance program
• Support teams in the initiation, review, and closure of quality events and associated CAPA, Change Action, and Effectiveness plans
• Develop and provide GCP and other GxP training (as applicable)
• Ensure appropriate qualification of vendors and ensure compliant vendor management and regular assessment/audits. May conduct GCP audits (vendors and sites)
• Ensure audit observations are communicated, tracked and remediated
• Provide QA GCP review and feedback on regulatory submissions
• Lead and participate in inspection readiness activities for regulatory inspections – both internally and at clinical sites
• Interface with internal departments and external vendors on a variety of technical/quality subjects

Qualifications

• 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.)
• GLP experience a plus
• Able to provide solution-minded approach and flexibility to emerging challenges
• Able to appropriately balance priorities plus multi-task against competing priorities
• Proven experience with the desire, and ability to work in a fast-paced, matrixed, start-up environment
• Hands-on leader, able to provide solution-minded approach and flexibility to emerging challenges
• Understanding of drug development and program management preferred