At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
Position Summary
The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, Label Operations and Warehouse Operations. This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. This position is a people manager position, leading a team of individual contributors in the Quality Assurance Shop Floor Organization.
Duties/Responsibilities
- Oversee performance of QA shop floor activities.
- Supervise Quality Assurance Shop Floor employees.
- Regularly spend time coaching and mentoring operators and QA personnel while on the manufacturing floor. Provide guidance and training on quality programs.
- Lead Quality on-the-floor oversight to Manufacturing/QC/Warehouse/ Packout operations/Label Operations. Proactively identify risks/critical issues and drive mitigations and escalate to management as needed.
- Develop, review and/or approve temporary and non-routine procedure for event response.
- Periodically observe operations. Proactively identify risks and drive improvements.
- Provide quality oversight to non-routine maintenance work. Review and approve return to service plans.
- Coordinate and lead area walkthroughs to identify quality issues. Negotiate remediations and drive alignment of implementation plans.
- Act as a QA subject matter expert on behalf of the facility during audits and inspections.
- Ensure manufacturing compliance with applicable procedures and batch records.
- Perform review of operational documentation including manufacturing batch records.
- Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
- Must be skilled in planning and organizing, decision-making, and building relationships.
- Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
- For markets requiring an Authorized Person (AP) release to be performed by Summit, act as designated AP performing Certification/Release for Supply in accordance with the PIC/S Guide to GMP (including Annex 16) and any local market requirements e.g. Australian Therapeutic Goods Administration (TGA) requirements, including the Therapeutic Goods Act 1989 and associated GMP principles.
- Perform verification and reconciliation of issued drug product labels.
Reporting Relationship
- Reports to the Senior Manager, Quality Assurance Shop Floor
Qualifications
Specific Knowledge, Skills, Abilities:
- Previous Supervisory/Managerial Experience is preferred.
- Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
- Understands continuous improvement and improves efficiency and productivity within the group or project.
- Builds relationships internally within and with cross functional teams.
- Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes.
- Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
- Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
- Able to recognize conflict and notify management with proposed recommendations for resolution.
- Requires little direction to complete more complex tasks; completes routine tasks with little or no supervision.
- Able to provide directions to others within the team.
- Confident in making decisions for non-routine issues.
- Develops and revises procedures.
- Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
- Able to prepare written communications and communicate problems to management with clarity and accuracy.
- Able to effectively multi-task.
Education/Experience/ Licenses/Certifications
- Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
- 6+ years of relevant cGMP experience, preferably with 2+ years of QA Shop Floor experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. Project management experience is preferred.
- Demonstrated experience with quality management systems.
- Demonstrated experience with electronic systems and databases such as Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP).
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview
Summit West - NJ - US: $93,910 - $113,794
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits
Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
Supporting People With Disabilities
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.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: 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/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.comwith the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
R1605668 : Quality Assurance Shop Floor Manager
