Senior Manager, Quality Assurance Material Operations, Cell Therapy

Bristol Myers Squibb EU Policy; Harvard (MA); On-site; USD 130,000 - 158,000; Full time

Benefits offered by this job

Health coverage

Wellbeing programs

401(k) plan

Paid time off

Job summary

Bristol Myers Squibb is seeking a Senior Manager, Quality Assurance Material Operations, Cell Therapy for our Devens, MA facility. You will lead the incoming material inspection, disposition programs, and master data systems (SAP and Syncade MES) to ensure compliance and timely material releases.

You will manage a team, interact with Quality Control, Supply Chain, and cross-functional groups, and drive continuous improvement while ensuring cGMP adherence across both commercial and clinical

Qualifications

• 8+ years in pharma or GMP industry.
• Bachelor’s degree in a biological science, engineering, or similar.

Responsibilities

• Oversee incoming material inspection and disposition programs.
• Manage SAP/MES master data approvals and eSystem master data.
• Lead and coach a team of professionals and first-line leaders.
• Represent Devens site in global material planning and quality initiatives.
• Review and approve quality procedures and materials release.
• Collaborate with QA, Supply Chain, and cross-functional teams.

Skills

cGMP

Decision making

Project leadership

Problem solving

Communication

Multi-tasking

Education

Bachelor's degree in biological science or engineering

Tools

SAP

Syncade MES

Job description

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.

The Senior Manager, Quality Assurance Material Operations, Cell Therapy role is responsible for the development, implementation, execution, and sustainability of quality and material disposition activities at the Devens, MA Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP. This individual will lead a team responsible for oversight and performance of the incoming material visual inspection, disposition, and eSystem master data programs. The individual will ensure timely and accurate delivery of disposition requirements from stakeholder groups such as Quality Control and supply chain. This individual will ensure compliant release of incoming raw materials and consumables, maintenance, and review of SOPs, and act as a Subject Matter Expert in projects and regulatory inspections. Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Devens. This role will work with Supply Chain, Manufacturing, Quality Control, Digital Plant, Supplier Quality, and other local and global stakeholder groups.

Duties/Responsibilities

• Must have knowledge and experience with cGMP manufacturing, Quality, and compliance.
• Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
• Must be action-oriented, customer-focused, and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Completes routine tasks with little or no supervision and moderate complexity tasks with input as needed from quality leadership.
• Confident in making decisions and problem solving for minor to moderate issues.
• Routinely recognizes Quality issues and opportunities for efficiency.
• Is recognized Subject Matter Expert within the group.
• Provides guidance to other employees in interpretation of complex data.
• Capable of providing input within the department and cross functional teams.
• Builds relationships internally within and with cross functional teams.
• Able to prepare written and verbal communications and convey problems to management with clarity and accuracy.
• Able to effectively multi-task.

Qualifications

• Responsible for oversight and implementation of the incoming material inspection and disposition programs
• Responsible for the oversight and implementation of highly complex and integrated eSystem quality master data approvals in ERP and electronic Batch Record systems (SAP and Syncade MES respectively).
• Hire, train, and coach a mix of single contributor and first line people leaders to execute the book of work and sustain programs.
• Represent the Devens facility in network initiatives for harmonization and at community of practices.
• Responsible for material control philosophy and oversight for the site
• Present and review the programs with internal, global, and health authority auditors.
• Approve Cohort to Material and other SAP/MES master data elements to support quality assurance
• Maintain quality Inspection Plans in SAP to align with procedural requirements for disposition activities.
• Oversee and approve all procedural documentation for incoming material programs.
• Approve new material requests for the site
• Interface with global Material Planning, Supply Chain, and Supplier Quality teams as Devens site representative.
• Perform impact assessments and own Quality System records for the incoming and master data programs.
• A minimum of 8 years of experience in the pharmaceutical or related GMP industry.
• A Bachelor’s degree in a biological science, engineering, or similar. An equivalent combination of education, military service, and experience will be considered.

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.

Compensation Overview (Devens - MA - US)

$130,020 - $157,559

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

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life Benefits Include

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

• Eligibility Disclosure: The summer hours program is for United States (U.S.) office‑based