Senior Manager, CTO Network QA Disposition

Role Summary

Senior Manager, QA Disposition Daily Operations, responsible for leading the drug product disposition activities at the S-12 Summit West facility (Summit West, Summit, NJ). The role oversees final release of drug product, reviews and approves site-specific procedures and GMP documentation in accordance with BMS policies and global cGMPs. The position leads a team to ensure timely and accurate disposition, maintains and reviews disposition SOPs, supports APQR generation, and serves as the site Subject Matter Expert in disposition. Work scope includes release for commercial and clinical manufacturing for all cell therapy products manufactured at Summit West, S-12 facility. Shift: onsite Tuesday–Saturday, 2:00 p.m. – 10:30 p.m.

Responsibilities

• Oversee the Drug Product disposition program at the site
• Oversee generation of all disposition certifications (Certificate of Analysis, Dose, RFI, etc.)
• Drive timely and efficient assessment of all disposition inputs (manufacturing batch records, QC testing, change controls, deviations, complaints, investigations, environmental monitoring results and CAPAs) prior to release
• Oversee and approve all SOPs and procedural documentation related to the drug product disposition program at the site
• Update and procure approval of job descriptions for department personnel; perform and oversee training, hiring, development, counseling, management, and performance appraisals
• Hire, train, and coach disposition personnel to execute the book of work and sustain Drug Product disposition programs
• Assure product quality and compliance by enforcing QA policies and procedures; ensure processes, procedures, systems, and resources are in place to enable compliant disposition of cell therapy products
• Communicate and update lot disposition status including communication at site and network levels
• Oversee compilation of and present disposition metrics to senior management
• Support site and functional teams during regulatory inspections or audits, including interaction with inspectors/auditors and writing/reviewing responses
• Represent the S-12 facility in network initiatives for harmonization and communities of practice
• Approve change controls related to disposition and associated activities including Quality Control specifications
• Perform projects as required by senior management

Qualifications

• Strong disposition experience required
• Minimum 8 years of relevant work experience within a cGMP environment
• Minimum 3 years of people leadership experience in the pharmaceutical or related industry

Skills

• Advanced knowledge and experience with cGMP manufacturing, quality, and compliance
• Ability to influence diverse, cross-functional teams to achieve disposition objectives
• Strong leadership with the ability to make and act on decisions while balancing speed, quality, and risk
• Effective written and verbal communication; ability to interact with internal and external cross-functional teams
• Conflict management and negotiation skills
• Ability to make independent decisions and work with little to no supervision; independent mindset
• Independently completes complex tasks; capable of multi-tasking; self-directed
• Confidence in making decisions for non-routine issues and driving resolution with senior management oversight
• Strong authorship and ability to critically review data and investigations, interpreting results to generate technical conclusions aligned with Quality risk management principles
• Deep knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, environmental monitoring programs, and CAPA management
• Experience leading continuous quality improvement initiatives to enhance site manufacturing efficiencies while maintaining safety and compliance
• Customer-focused, action-oriented, with strong problem solving, planning, organizing, resource allocation, coaching, and analytical thinking skills
• Recognized as a Subject Matter Expert within the group, site, and network; can guide others in interpretation of complex data
• Excellent verbal and written communication skills

Education

• Bachelor's degree in a biological science, engineering, microbiology or similar; equivalent combination of education and experience will be considered