Senior Manager, CTO Network QA Disposition

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

At Bristol Myers Squibb, we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The 2nd Shift Senior Manager, QA Disposition Daily Operations is responsible for leading the drug product disposition activities at the S-12 Summit West facility. Responsibilities include overseeing final release of drug product, review, and approval of site-specific procedures and GMP documentation in accordance with BMS policies, standards, procedures and global cGMPs. This individual will lead a team responsible for ensuring timely and accurate delivery of disposition requirements, maintenance and review of disposition associated SOPs, support of APQR generation and function as a Subject Matter Expert in disposition for the site. Work scope will include release for commercial manufacturing and clinical manufacturing for all cell therapy products manufactured at the Summit West, S-12 facility.

Shift Available:

• Tuesday - Saturday, Onsite Afternoon Shift, 2 p.m. - 10:30 p.m.

Responsibilities

• Responsible for the oversight and implementation of the Drug Product disposition program at the site

• Oversee the generation of all disposition certification as applicable; Certificate of Analysis (CoA), Dose, RFI (release for infusion) certificate, etc.

• Drives and oversees the timely and efficient assessment of all disposition inputs i.e. manufacturing batch records, QC testing, change controls, deviations, complaints, investigations, environmental monitoring results and CAPAs associated to drug product prior to release

• Oversees and approves all standard operating procedures (SOPs) and procedural documentation related to the drug product Disposition program at the site.

• Updates and procures approval of job descriptions for department personnel. Performs and oversees the training of personnel. Effectively hires, develops, counsels, manages, and motivates staff. Writes and administers performance appraisals for department personnel.

• Hire, train, and coach disposition personnel to execute the book of work and sustain Drug Product disposition programs.

• Assures product quality and compliance by enforcing quality assurance policies and procedures; ensures the required processes, procedures, systems, and resources are in place to enable a compliant disposition of cell therapy products.

• Responsible for communicating and updating lot disposition status including communication at site and network levels.

• Oversees compilation of and presents disposition metrics to senior management.

• Supports site and functional teams during regulatory inspections or audits, which may include direct interaction with inspectors/auditors as well as writing and/or reviewing responses.

• Represent the S-12 facility in network initiatives for harmonization and at community of practices.

• Approve change controls related to disposition and associated activities including Quality Control specifications.

• Performs projects as required by senior management.

Knowledge & Skills:

• Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.

• Demonstrated ability to work in an organization with a range of technically, culturally, and geographically diverse teams, to influence are