Director – Quality GCP

Role Summary

Director Quality GCP responsible for 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. Requires 75% on-site presence and collaboration with teams in Boston and Basel.

Responsibilities

• Primary GCP Quality contact for identified vendors and investigator sites supporting clinical programs and other GCP quality events (e.g., potential serious breach assessments, CAPAs).
• Author key GCP quality SOPs and serve as reviewer for other quality (GxP) procedures.
• Develop a risk-based GCP compliance program.
• Support 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 compliant vendor management with regular assessments/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 internally and at clinical sites.
• Interface with internal departments and external vendors on technical/quality subjects.

Qualifications

• BS Degree in Chemistry, Pharmacy, Biology or a related life science, or combination of 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 is a plus.
• Able to provide a solution-minded approach and flexibility to emerging challenges.
• Able to balance priorities and multi-task against competing demands.
• Proven ability to work in a fast-paced, matrixed, start-up environment.
• Hands-on leadership with a practical, solution-focused mindset.
• Understanding of drug development and program management is preferred.

Skills

• GCP and GxP quality management
• Vendor qualification and audit management
• Regulatory submissions support and inspection readiness
• Risk-based compliance program development
• Training program development and delivery
• Cross-functional collaboration in a matrixed environment

Education

• BS in Chemistry, Pharmacy, Biology or related life science (or equivalent combination with relevant quality experience)