JCW Group
Senior Director, Quality Assurance
An established and rapidly growing pharmaceutical manufacturer is seeking a Senior Director of Quality Assurance to lead inspection readiness and quality oversight across multiple U.S. sites. This is a high‑impact enterprise role for a strategic QA leader experienced in sterile manufacturing and FDA‑facing quality operations.
Key Responsibilities Lead all FDA inspection readiness and agency interactions. Oversee quality systems, including training, internal audits, supplier quality, and customer complaints. Guide a multi‑site QA organization through compliance, remediation, and continuous improvement. Manage and develop regional quality leaders and site QA staff (approx. 10–15 total reports).
Ideal Profile 10+ years of progressive QA leadership. Proven success managing FDA inspections and remediation programs. Strong understanding of enterprise quality systems and experience with multi‑site oversight. Collaborative, hands‑on leader able to drive structure and inspection readiness. Experience working with sterile products.
Seniority Level Director
Employment Type Full‑time
Job Function Quality Assurance, Management, and Training
Industries Pharmaceutical Manufacturing and Biotechnology Research
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Key Responsibilities Lead all FDA inspection readiness and agency interactions. Oversee quality systems, including training, internal audits, supplier quality, and customer complaints. Guide a multi‑site QA organization through compliance, remediation, and continuous improvement. Manage and develop regional quality leaders and site QA staff (approx. 10–15 total reports).
Ideal Profile 10+ years of progressive QA leadership. Proven success managing FDA inspections and remediation programs. Strong understanding of enterprise quality systems and experience with multi‑site oversight. Collaborative, hands‑on leader able to drive structure and inspection readiness. Experience working with sterile products.
Seniority Level Director
Employment Type Full‑time
Job Function Quality Assurance, Management, and Training
Industries Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr