Sr. Director, Quality Operations

This is a full-time hybrid position based in our Somerville, Massachusetts (Assembly Row) office, with an onsite presence required three days per week. Candidates must reside within a commutable distance of the office to be considered.

The Senior Director, Quality Operations is a senior quality leader responsible for providing strategic and operational leadership for commercial Quality Operations, including external manufacturing and testing oversight, lot disposition, quality governance, and patient-specific product controls across clinical and commercial-stage supply. This role is critical in a virtual operating model and ensures that all Contract Development and Manufacturing Organizations (CDMOs), testing laboratories, and other GxP service providers operate in full compliance with global regulatory requirements and company quality standards.

This role partners closely with Manufacturing, Technical Operations, Supply Chain, Regulatory Affairs, Medical, Patient Operations, and Commercial teams to ensure uninterrupted and compliant patient supply, timely quality decisions, and sustained inspection readiness as the organization scales.

RESPONSIBILITIES

External Manufacturing Quality Oversight

• Provide end-to-end quality oversight of external manufacturers (CDMOs) supporting clinical and commercial cell and gene therapy products.
• Establish and maintain CDMO quality agreements, ensuring clear delineation of responsibilities for commercial operations.
• Oversee performance monitoring, periodic review, and ongoing approval of CDMOs, contract testing laboratories, logistics providers, and other critical GxP service providers.
• Establish risk-based quality scorecards and ensure significant performance or compliance concerns are escalated and remediated.
• Serve as the primary quality point of contact for assigned external partners, fostering strong, collaborative relationships.

Commercial Product Support

• Ensure compliant commercial product release, disposition, and lifecycle management, including deviations CAPAs, change controls, and investigations.
• Oversee lot disposition activities in collaboration with internal stakeholders, ensuring timely and compliant decision-making.
• Provide independent Quality oversight and make or escalate timely decisions regarding product quality, patient impact, lot disposition, and regulatory compliance.
• Ensure robust controls for chain of identity, chain of custody, patient-specific labeling, product traceability, sample management, and temperature-controlled transportation.
• Support the Annual Product Quality Reviews/Product Quality Reviews and product-quality trending for assigned products and external manufacturing sites.
• Support process validation, continued process verification (CPV), comparability assessments, and post-approval changes.

Regulatory & Inspection Readiness

• Lead external quality readiness for FDA inspections, including PAIs and commercial inspections.
• Participate directly in regulatory inspections and audits as a company representative.
• Ensure timely and effective resolution of inspection findings, observations, and commitments.
• Partner with Regulatory Affairs to support regulatory filings, post-approval changes, regulatory commitments, and assessments of potentially reportable quality events.

 Audit & Compliance Leadership

• Ensure effective management of CDMO audit observations, deviations, and CAPAs to closure.
• Monitor compliance trends and proactively identify and mitigate quality risks across the external network.

Quality Systems & Governance

• Drive continuous improvement of external quality processes aligned with a virtual operating model.
• Ensure external partners comply with company Quality Management System (QMS), including documentation, training, data integrity, and change management.
• Contribute to enterprise-level quality metrics, governance forums, and management reviews.

 Leadership & Cross-Functional Partnership

• Lead, mentor, and develop a high-performing Quality Operations team.
• Act as a strategic quality advisor to senior leadership and cross-functional teams.
• Support company growth through onboarding of new external partners and technologies.
• Establish clear priorities, resource plans, roles, and accountability for the Quality Operations organization.
• Develop organizational capability through coaching, succession planning, technical development, and performance management.
• Serve as an escalation point for significant product-quality, compliance, patient-supply, and external-partner issues.

QUALIFICATIONS 

 Required Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related discipline (advanced degree preferred).
• 12+ years of progressive experience in Quality Operations, External Quality, or Manufacturing within
• Prior people leadership experience at the Director or Senior Director level.
• Demonstrated experience supporting commercial-stage products and post-approval lifecycle management.
• Deep knowledge of GMP regulations (FDA, EMA, ICH) applicable to biologics and advanced therapies.
• Proven success working in a virtual or highly outsourced operating model.
• Experience supporting global regulatory inspections.

 Preferred Qualifications

• Experience with autologous and/or allogeneic cell therapy manufacturing models.
• Experience supporting BLA/MAA submissions, post-approval changes, and commercial expansions.

 Key Competencies

• Strategic thinking with strong operational execution
• Strong decision-making and risk-based quality mindset
• Ability to influence and lead without direct authority
• Excellent communication and executive presence
• Comfortable operating in fast-paced, evolving environments