Sr. Manager, Quality Assurance for Quality Control
$145,000–$196,000 year
HybridSomerville, Massachusetts, United States
Job Summary
Manage Quality Control communications with contract testing and manufacturing organizations while leading the stability program for commercial products. Own quality systems for deviations, laboratory investigations, and CAPAs, ensuring all documentation complies with cGMP regulations. Facilitate internal and external meetings with CTO partners to support change management and regulatory filings, and track issues impacting testing to resolve them timely. Lead the team on activities related to quality operations and process improvement initiatives across the department. This full-time hybrid role (3 days a week) in Somerville, MA, supports curative gene therapy development and includes an annual bonus and long-term incentives.
Required Qualifications
- BS or MS in a scientific discipline
- 5–10+ years of experience in a QC cGMP clinical and/or commercial environment
- Experience managing CTOs and CMOs
- strong interpersonal and partner-management skills
- Stability program management experience
- familiarity with ICH guidelines
- Direct people-management experience
- management of teams or individual contributors
- Excellent organizational skills
- ability to succeed in a fast-paced environment
- Experience with quality systems supporting deviations, laboratory investigations, and CAPAs
- Strong working knowledge of cGMP, ICH, FDA, and EMA regulations
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