Sr. Director, Quality Operations

Role: Senior Director, Quality Operations at a biopharma focused on gene therapies, overseeing quality for clinical and commercial cell and gene therapy products. Responsibilities: provide strategic and operational leadership for external manufacturing and testing oversight, ensuring compliance with GMP and regulatory standards; manage relationships with CDMOs, contract testing labs, and logistics providers; oversee product release, lot disposition, deviations, CAPAs, change controls, and investigations; lead inspection readiness, participate in regulatory audits, and support filings including post-approval changes; drive quality systems improvements, compliance monitoring, and governance; mentor and develop the Quality Operations team and act as strategic quality advisor to senior leadership. Requirements: Bachelor’s in Life Sciences, Engineering, or related field; 12+ years in Quality Operations, with prior experience supporting commercial-stage biologics or advanced therapies; proven leadership at the Director or Senior Director level; deep GMP knowledge (FDA, EMA, ICH); experience in a virtual/outsourced manufacturing model and supporting global regulatory inspections. Preferred: experience with autologous/allogeneic cell therapies, BLA/MAA submissions, and post-approval product lifecycle. High-Value: expertise in biologics or cell/gene therapies, post-market quality management, GMP compliance, and regulatory interactions. Work setup: hybrid in Somerville, MA, with onsite presence three days per week; candidates must reside within a commutable distance.