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 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.

BMSCART, #LI-Onsite

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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 https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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