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.

• 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.

• 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.