2nd Shift Senior Manager, QA Disposition Daily Operations
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.
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 siteOversee 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 releaseOversees 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 areas not under direct control to achieve disposition objectives.Demonstrated strong leadership capability with the ability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results that meet high-quality requirements with tight deadlines.Can effectively communicate simple and complex issues in written format or in person through face-to-face or virtual environments.Effectively communicates internally within the function and with internal and external cross-functional teams. Interacts well with internal and external cross-functional teams.Manages conflict and issues with internal and external customers. Demonstrates strong negotiation skills in internal and external cross-functional teams.Ability to make independent and objective decisions and to work with little to no supervision.Must possess an independent mindset.Independently completes complex tasks; completes routine tasks with no supervision.Able to effectively multi-task.Work is self-directed.Confident in making decisions for non-routine issues.Proposes solutions for complex issues and drives resolution with senior management oversight. Follows established procedures and performs work as assigned.Advanced ability to interpret results and situations and articulate recommendations for resolution.Must have strong authorship and ability to critically review data and investigations, interpret results and generate technical conclusions consistent 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.Manages quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.Must possess an independent mindset and tenacity.Routinely recognizes Quality issues and solves problems.Is recognized as Subject Matter Expert within the group, site and network.Provides guidance to other employees in interpretation of complex data.Contributes to goals within the work group.Excellent verbal and written communication skills.Basic Requirements
A Bachelor's degree in a biological science, engineering, microbiology or similar. An equivalent combination of education and experience will be considered.Strong Disposition experience required.A minimum 8-years relevant work experience within a cGMP environment.A minimum 3-years of people leadership experience in the pharmaceutical or related industry.Work Conditions
Work is performed in a typical office environment, with standard office equipment available and used.Work is generally performed seated but may require standing and walking for up to 10% of the time.Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.Compensation Overview : Summit West - NJ - US : $143,180 - $173,504
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit.
Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role : Site-essential roles require 100% of shifts onsite at your assigned facility. Site
