Senior Manager, Quality Assurance Shop Floor 2nd Shift

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. 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: Senior Manager, Quality Assurance Shop Floor 2nd Shift

Location: Devens, MA

Position Summary

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.

Work Schedule:

• Standard Hours: 3:00 PM start, Monday to Friday, on-site at Devens, MA

• Shift Leadership: Oversee two night-shift managers and respective teams working an alternate 3-2-2 Panama schedule from 6:00 PM to 6:00 AM, 7 days a week.

Key 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.

What We’re Looking For:

• 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.

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 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.).

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Devens - MA - US: $130,020 - $157,559

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.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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 you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1598585 : Senior Manager, Quality Assurance Shop Floor 2nd Shift