Director – Quality GCP

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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

Skills

Education

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