Director, GMP Operational Quality

General/Position Summary
- Oversee GMP QA operations, including batch disposition, across CDMOs in the US and internationally.
- Provide day-to-day operational quality oversight for internal batch record review and QA manufacturing operations from clinical to commercial stages globally.
- Partner with operational stakeholders to lead/support quality & technical risk mitigation and governance for improvements to the disposition process.
- Collaborate with internal and external stakeholders to drive compliance and continuous improvement. May support on-site internal manufacturing activities.
- On-site role (five days per week) in Boston Seaport.

Key Duties & Responsibilities
- Establish quality oversight for internal quality and external CTO/CDMO batch disposition across development, launch, and commercial manufacturing globally.
- Drive continuous improvements; identify and mitigate compliance gaps; promote a culture of quality.
- Manage day-to-day timely release of finished product to ensure compliance with regulatory and cGMP requirements.
- Represent Quality as a trusted partner for drug product disposition.
- Lead and mentor team members; develop organizational capabilities and talent.
- Ensure CDMO disposition activities are compliant and consistent.
- Ensure adequate training for department personnel.
- Manage department resources (budget and personnel).
- Build strategic relationships with CDMOs and CTOs; ensure quality issues are raised and addressed.
- Develop Batch disposition operational quality and compliance metrics.
- Act as batch disposition SME for regulatory inspections and audits.
- Establish/participate/lead GxP Cell & Gene Therapy Management Reviews.
- Support Health Authority inspections, respond to information requests, adjudicate compliance discussions, and negotiate corrective actions.
- Represent C&G Quality in complex projects and strategic/operational planning.
- May support on-site manufacturing activities.

Required Education
- Bachelor’s degree or Master’s degree (or equivalent).

Required Experience
- 10+ years of experience, including 5+ years in a management/supervisory role (or equivalent in a regulated pharmaceutical environment).

Required Knowledge/Skills
- Global regulatory agency knowledge across GxP lifecycle for Cell & Gene therapy and/or biologics (EU GMPs, FDA 21 CFR Part 1271, GxPs).
- Knowledge of batch disposition industry trends and best practices for Cell/Gene therapies.
- Broad technical knowledge: cell technology, aseptic manufacturing, analytical assays, cell & genetic therapies/biologics processing, fill/finish, and testing.
- Strategic planning and execution; root cause analysis, data analytics, and operational excellence (LEAN, DMAIC, Six Sigma).
- Excellent communication; ability to influence and build a culture of quality and excellence.
- Risk management for decision-making and operational priorities.
- Critical thinking and problem solving.
- Ability to collaborate and build relationships with internal and external stakeholders.
- Preferred: QA operational experience for Autologous Cell Therapy Operations.

Other Requirements
- Up to 15% travel may be required.