Director, Quality Disposition Operations

Bristol-Myers Squibb - Devens, MA

Full-time - Senior

Devens, MA

Chemical Manufacturing

About the position

The Director, Quality Disposition Operations at Bristol Myers Squibb is a pivotal role responsible for the development, implementation, and sustainability of processes related to the disposition of incoming materials and commercial final drug products at the Devens Cell Therapy Facility (CTF). This position entails overseeing the day-to-day evaluation of product quality and the disposition of products produced at the Devens CTF. As a key leader within the Devens CTDO Quality team and a member of the Quality Leadership team, the Director will champion quality principles and compliance throughout the organization. The role requires a hands-on approach, as the Director will occasionally perform the lot disposition process for batches produced at the facility. The scope of work encompasses both commercial and clinical manufacturing for all cell therapy products produced in Devens. In this role, the Director will collaborate closely with various departments, including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, and MS&T, to ensure that all quality standards are met and maintained. The Director will also be responsible for developing and continuously improving processes to ensure timely product disposition, managing the disposition activities for clinical and commercial finished drug products, and ensuring that all relevant documentation associated with a lot is accounted for, completed, and approved by the appropriate individuals. This position is stationed in Devens, MA, and reports directly to the Executive Director, Quality for the Devens Cell Therapy Facility.

Responsibilities

• Develop and implement processes for the disposition of incoming materials and commercial final drug products.
• Evaluate product quality and disposition of products produced at the Devens CTF on a day-to-day basis.
• Lead a team of Quality professionals responsible for product disposition.
• Perform the lot disposition process for batches produced at the Devens CTF as needed.
• Collaborate with Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, and MS&T.
• Manage the disposition activities for clinical and commercial finished drug products.
• Ensure all relevant documentation associated with a lot is accounted for, completed, and approved.
• Develop and improve processes for the review and approval of QC documentation related to each lot.
• Lead the site Material Review Board (MRB) meetings and evaluate recommendations made during product disposition.
• Contribute to the development and execution of the Pre-Licensing Inspection (PLI) and commercialization readiness plan at the Devens CTF.

Requirements

• BS/MS in relevant Science or Engineering discipline.
• 10+ years of experience in managing Quality Assurance or Manufacturing function.
• Minimum 7 years of people management experience.
• Expertise in GMP compliance and FDA/EMA regulations.
• Experience with implementing and overseeing GMP operations in a plant manufacturing both clinical and commercial products.
• Background in Protein Biologics or Cell Therapy Manufacturing is strongly preferred.
• Demonstrated experience building and leading exceptional teams.
• Ability to effectively lead a team, drive accountability, and prioritize deliverables.
• Experience leading in a dynamic, collaborative, and fast-paced environment.
• Understanding of financial principles, core business concepts, and business management.

Nice-to-haves

• Experience in a leadership role within a pharmaceutical or biotechnology company.
• Familiarity with electronic systems such as MES (Manufacturing Execution System) and SAP.

Benefits

• Competitive salary and benefits package.
• Opportunities for professional growth and development.
• Flexible work environment with a focus on work-life balance.