Position SummaryThe Senior Manager, Quality Assurance Shop Floor (QASF) Day Shift is a key people leader. The incumbent manages front line managers, and their teams, and will play a pivotal role in ensuring the highest quality standards in our cGMP Cell Therapy processes. The QASF organization is responsible for quality oversight of shop-floor activities at the Devens Cell Therapy Facility (CTF) including the manufacturing, release testing, and packaging of autologous drug product.
- The incumbent will be at the forefront of our day shift operations, fostering a culture of quality.
- They will be responsible for the hiring, training, and leadership of 4 day-shift managers and their respective teams, ensuring they are equipped to meet and exceed quality standards.
- They work in a dynamic setting needing to influence cross-functionally, problem solve and be the senior Quality Assurance leader representing the day shifts.
- This role combines quality, compliance, and leadership, ideal for someone eager to coach and support a growing team.
Work Schedule:
- Standard Hours: Routine Business Hours, Monday to Friday
- Shift Management: Oversee four day-shift managers and respective teams working an alternate 3-2-2 Panama schedule from 6:00 AM to 6:00 PM, 7 days a week.
Key Responsibilities:
- Lead and mentor day-shift managers and their teams, ensuring effective communication and high performance.
- Uphold and improve quality standards through cross-functional collaboration and influence.
- Develop and implement training programs to enhance the technical acumen and effectiveness of the day-shift teams.
- Utilize your analytical thinking to solve complex quality issues and drive continuous improvement.
What We're Looking For:
- A high degree of technical acumen and a strong desire to learn.
- Proven leadership skills with the ability to mentor and develop staff.
- Excellent communication and analytical thinking abilities.
- A proactive approach to cross-functional collaboration and quality improvement.
- The Senior Manager will lead their teams to ensure patient safety in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures, and Global current Good Manufacturing Practices (cGMPs).
- This position reports to the Associate Director, Quality Assurance Shop Floor and is a part of the QASF Leadership Team.
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 and/or represent QA in leadership, staff and tier meetings, governance forums or on project teams.
- Act as a QA subject matter expert on behalf of the facility during audits and inspections.
- Provide timely QASF support to site compliance activities such as Change Control impact assessments, deviation impact assessments, and development of corresponding CAPAs.
- 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 on-site quality operations teams working 12-hour shifts 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 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.
- Skilled in building relationships, influencing across the matrix, and coaching others to drive results.
- Fosters a positive team environment and culture by being a mentor to, and advocate for, team-members.
- 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.
- Master's degree in STEM or an MBA preferred. Bachelor/Associates degree with equivalent combination of education and work experience is considered.
- 8+ years of relevant cGMP experience, preferably with 4+ year of manufacturing site experience.
- Ability to work within pharmaceutical cleanroom environments.
WORKING CONDITIONSPHYSICAL /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:Devens - MA - US: $130,020 - $157,559
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 WorkWhere 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.
R1606280 : Senior Manager, Quality Assurance Shop Floor
