Senior Manager, Quality Assurance Shop Floor 2nd Shift

Bristol Myers Squibb • Devens, MA

21h • Onsite

About The Position

The Senior Manager, Quality Assurance Shop Floor (QASF) 2nd 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 night shift operations, fostering a culture of quality. They will be be responsible for the hiring, training, and leadership of two night-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 night shifts. This role combines quality, compliance, and leadership, ideal for someone eager to coach and support a growing team.

Requirements

• A high degree of regulatory, quality and compliance 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.
• 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.
• 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.
• 8+ years of relevant cGMP experience, preferably with 4+ year of manufacturing site experience.
• Ability to work within pharmaceutical cleanroom environments.

Nice To Haves

• Experience working in aseptic/sterile environments and/or in quality control operations focused on microbial controls and contamination mitigation strategies is preferred.
• 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.

Responsibilities

• Lead and mentor night-shift managers and their teams, ensuring effective communication and quality performance.
• Uphold and improve quality standards through cross-functional collaboration and influence.
• Develop and implement continuous improvement efforts to enhance the quality and compliance acumen and effectiveness of the night-shift teams.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level