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 rich in diversity. 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 .
POSITION SUMMARY
As the Senior Manager Days, Quality Assurance Shop Floor (QASF) you play a pivotal role in ensuring the highest quality standards in our cGMP processes. This is not just a job; it’s an opportunity to lead, innovate, and make a significant impact on our organization.
- As a critical on-site leader, you will be at the forefront of our day shift operations, driving excellence and fostering a culture of quality.
- You’ll be responsible for the staffing, training, and leadership of two day-shift managers and their respective teams, ensuring they are equipped to meet and exceed quality standards.
- Work in a dynamic setting where your ability to cross-functionally influence and improve quality standards will be highly valued.
- This role offers a unique blend of technical challenges and leadership opportunities, perfect for someone with a strong desire to learn and grow.
Work Schedule:
- Standard Hours: Routine Business Hours, Monday to Friday
- Shift Management: Oversee two day-shifts staffed from 6:00 AM - 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 QASF organization is responsible for supporting shop-floor activities at the Devens Cell Therapy Facility (CTF) for the manufacturing, release testing, and packaging of autologous Cell Therapy drug product.
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.
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.
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