Position SummaryThe 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.
Wednesday to Saturday - 12-hour shift (every other Wed off)
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.
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).
Compensation Overview:Summit West - NJ - US: $93,910 - $113,794
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 in effect at the time and may require enrollment. Our benefits include:
- 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 employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
