Associate Director, QA Manufacturing Technical Services
$156,600–$234,800 year
On-site · Boston, Massachusetts, United States
Job Summary
Lead and oversee deviation management across internal manufacturing for Cell & Gene therapy through the quality management system, providing QA oversight from facility start-up to commercialization, post-approval monitoring, and deviation closure. Partner with Manufacturing, Quality Control, MSAT, Engineering, Supply Chain, Regulatory Affairs, and other Quality functions to ensure regulatory compliance and timely resolution of deviations; drive CAPA and root cause analysis, support risk assessments, and lead continuous improvement initiatives. Provide routine on-the-floor quality support for manufacturing operations, lead audits, and maintain audit-ready deviation records. Requires a Bachelor's degree in biotech/life sciences and 8+ years of industry experience; deep knowledge of regulatory environments (FDA/EMA/cGMP) and quality systems; strong leadership, communication, and cross-functional collaboration skills; familiarity with electronic document management systems (Trackwise, Veeva).
Required Qualifications
- Bachelor's degree in biotech/life sciences
- 8+ years of relevant industry experience in biotechnology/regulated pharmaceutical environment
- Experience with deviation management, CAPA, root cause analysis
- Strong knowledge of regulatory standards (FDA, EMA, cGMP) and quality systems
- Ability to lead cross-functional teams
- On-floor QA support experience
- Strong communication and leadership skills
- Experience with electronic document management systems (e.g., Trackwise, Veeva)
- Knowledge of risk assessment and continuous improvement methodologies
- Master's degree or relevant comparable background is a plus
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