Sr. Director, Quality Compliance
$250,000–$273,000 year
Hybrid · Lexington, Massachusetts, United States
Job Summary
Senior leadership role overseeing global quality compliance programs, with governance of supplier oversight, product quality complaints, and inspection readiness. Drives risk-based quality culture across development through commercialization, partners cross-functionally to align with regulatory expectations (FDA/EMA/MHRA/ICH), and leads quality systems optimization (deviations; CAPA; change control; QMS with platforms like Veeva and TrackWise). Requires 12+ years in QA/Compliance in pharma/biotech, advanced scientific degree, and proven experience in regulatory inspections, supplier quality management, and cross-functional leadership. Location in Lexington, MA with a hybrid schedule (4 days in office, 1 day remote) and up to 30% travel; salary range $250k-$273k.
Required Qualifications
- Advanced degree in a scientific discipline (MS, PhD, or equivalent preferred)
- 12+ years of experience in Quality Assurance/Compliance within the pharmaceutical or biotechnology industry
- Experience leading GMP, GCP, and/or GLP environments across development and commercial stages
- Extensive experience with regulatory inspections and health authority interactions
- Proven expertise in supplier quality management, product complaints, and inspection readiness
- Experience with electronic Quality Management Systems (e.g., Veeva, TrackWise)
- Strong knowledge of global regulatory requirements (FDA, EMA, ICH)
- Leadership competencies: strategic thinking, executive communication, risk-based decision making, change leadership, operational excellence
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