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Manager, Shop Floor Quality Assurance,… at Bristol-Myers… · Devens -…
Job Description
Manager, Shop Floor Quality Assurance, Cell Therapy
Location: Devens - MA - US
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.
Shift:
Day Shift, 6am - 6pm, rotating schedule including holidays and weekends, onsite
This is a key role on the Shop Floor Quality Assurance team. As Shift Manager for the A1 Shift (6am to 6pm), you will lead a team of 4-8 Specialists.
The Shop Floor Quality Assurance team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations.
This position will oversee and partner with operational teams to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.
The Manager, Shop Floor Quality Assurance, Cell Therapy is responsible for quality activities for the Cell Therapy Facility in accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring operational compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues.
The Manager, Shop Floor Quality Assurance role is stationed in Devens, MA and reports to the Senior Manager, Field Quality Assurance for the Devens CTF.
Key Responsibilities
Provide leadership to ensure routine on-the-floor Quality oversight and to ensure collaborative triages of unexpected events within the Manufacturing, Quality Labs, and Supply Chain operational areas and systems.
Have a comprehensive understanding of Cell Therapy processes to enable real-time decision-making.
Advanced ability to synthesis information from multiple sources, interpret problems and effectively communicate to cross-functional management in a clear, brief, and accurate manner.
Respond to complex/critical issues and build a consensus of understanding with subject-matter experts for product impact and justification to continue manufacturing.
Serve as a subject matter expert supporting others to navigate the BMS quality management system including but not limited to deviation and CAPA action management, interim production controls, disposition decisions, and batch record management.
Provide direction and timely guidance to QA shift-managers regarding the handling and resolution of cGMP events which may be a part of deviations, batch record exceptions, and other quality operational issues.
Accountable for the performance/delivery of the QA field quality organization, including oversight of the “QA on-the-floor” systems and programs that enable the highest quality and the quickest delivery of QA cGMP tasks.
Develop and implement standard-work for team-members that balances on-floor support for non-routine events, routine quality assurance work, and stretch/development project-work.
Champion a culture that embraces psychological and physical safety of employees in the work environment.
Champion a culture of teamwork, communication, and continuous improvement focused on defining problem statements, driving initial investigative efforts, and actioning solutions to reduce recurrence.
Proactively identify and address quality risks and critical issues, drive mitigations with the aid of Field Quality Staff and cross-functional partners and escalate to senior management as needed.
Lead walkthroughs with peers or QA team-members to identify and remediate operational or quality issues.
Review and interpret the technical conclusions of a record/investigation and provide constructive feedback.
Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge
Regularly spend time coaching and mentoring operators and Field QA specialists while on the manufacturing floor.
Interview, hire, coach, motivate, and develop exceptional staff. Set performance objectives and development plans. Monitor performance progress and conduct performance reviews for all direct reports.
Qualifications & Experience
Ability to lead an on-site quality operations teams working a 6am to 6pm shift on a rotating 2-3-2 Panama schedule.
Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management.
Experience working in aseptic/sterile environments and/or in quality control operations focused on microbial controls and contamination mitigation strategies is preferred.
Ability to research, understand, interpret, and apply internal policies and regulatory guidelines
Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications.
Advanced ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions.
Excellent written and verbal skills and advanced ability to present technical data effectively based on target audience
Ability to work in a fast-paced team environment and lead peers through changing priorities
Ability to think strategically, meet deadlines, and support work prioritization
Ability to negotiate and influence to craft mutually beneficial solutions
Ability to motivate and foster a positive team environment
Exhibit strong decision-making and ability to think creatively while maintaining compliance and quality
Pioneering mindset and ability to create innovative solutions
Ability to think strategically, with an enterprise-mindset, establish deadlines and prioritize work according to the needs of the business and within budget.
Ability to research, understand, interpret, and apply internal policies, cGMP, and quality principles.
Establishment of strategic goals, departmental objectives, and motivating team to achieve operational tasks.
Exhibits strong decision-making ability and analytical thinking while maintaining compliance and quality.
Proactively finds solutions to quality and operational problems by creative thinking and innovative solutions.
Proven ability to negotiate mutually beneficial solutions and resolve differing perspectives among stakeholders.
Ability to understand complex problems with multiple datum/variables and articulate practical solutions.
Excellent technical writing/verbal skills. Ability to effectively present technical data based on target audience.
Demonstrated experience working with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or Quality Management Systems such as TrackWise or Veeva.
Ability to lead change in a fast-paced environment with limited information and/or time-constraints.
Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is required.
Experience with microbial controls, lean or six-sigma improvements, or as a technical/scientific process engineer in the biopharmaceutical industry preferred.
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+ year of QA shop floor experience.
Ability to work within pharmaceutical cleanroom environments.
WORKING CONDITIONS
PHYSICAL /MENTAL DEMANDS:
Able to work near strong magnetic fields.
Able to gown for ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, etc.).
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:
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.
R1606315 : Manager, Shop Floor Quality Assurance, Cell Therapy