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Manager, Quality Assurance Investigations, Cell Therapy
Manager, Quality Assurance Investigations, Cell TherapyBristol Myers Squibb • Devens, Massachusetts, USA
Manager, Quality Assurance Investigations, Cell Therapy

Manager, Quality Assurance Investigations, Cell Therapy

Bristol Myers Squibb • Devens, Massachusetts, USA
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  • [job_card.full_time]
  • [job_card.part_time]
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Working with Us

Challenging. Meaningful. Life-changing. Those arent 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. Youll 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 : Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition backed by a best-in-the-industry team and long-term commitment we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself accelerate your career and give new hope to patients theres no better place than here at BMS with our Cell Therapy team.

The Manager QA Investigations is responsible for quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records at the Devens Cell Therapy Facility. The role provides Quality oversight and assurance of the quality of manufactured products in compliance with all applicable regulations and BMS policies and guidelines.

Shifts Available : TBD

Responsibilities :

  • Review and approve complex investigations / CAPAs / effectiveness checks associated with all aspects of manufacturing process including incoming manufacturing laboratory facility and utility systems.
  • Author review approve technical reports including but not limited to risk assessments and deviation system monitoring reports to support the deviations program.
  • Ensure the corrective / preventive actions are robust and adequately address the root cause.
  • May perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions.
  • Drive deployment of effective deviation processes within representative site / function.
  • Coach employees on aspects of investigations.
  • Resolve investigational process or system issues.
  • Ensure appropriate issues are cascaded to global team and liaise with global team on routine basis.
  • Provide relevant monitoring of functional area deviation metrics.
  • Champion for culture of quality within the deviation program.
  • Proactively monitor metrics and take relevant actions (including work prioritization) to ensure that disposition timelines and other targets are met.
  • Identifies improvement opportunities and drives execution of site / team continuous improvement goals and projects.
  • Support internal and external inspections as required.
  • May present individual topics during audits as needed.
  • Maintain compliance with assigned learning plan. Support development and delivery of training content to cross functional teams.
  • Support integration of newer team members
  • Acts as Subject Matter Expert of the root cause analysis and investigations process and provides guidance / coaching to less experienced staff with atypical events during day-to-day operations.
  • Lead meetings and represent function at cross functional and network meetings.

Knowledge Skills Abilities :

  • Ability to research understand interpret and apply internal policies and regulatory guidelines.
  • Proficient computer skills with knowledge of several digital tools like MS Office Smartsheets etc. and ability to learn and work with new software applications.
  • Demonstrated experience to interpret complex data & results understand significant problems with multiple variables and critically assess and provide feedback on proposed CAPA.
  • Demonstrated experience to critically review investigation reports interpret results and assess and challenge technical conclusions consistent with Quality risk management principles.
  • Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy.
  • 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.
  • Able to independently work across functional groups and teams to ensure requirements are met.
  • Ability to motivate and foster a positive team environment.
  • Confident in making decisions able to anticipate Quality issues and proactively solve problems.
  • Curious and ability to think critically to create innovative solutions.
  • Minimum Requirements :

  • Bachelors degree in STEM field preferred. High school diploma / Associates degree with equivalent combination of education and work experience may be considered.
  • 6 years of experience in a regulated industry preferably with 2 year of deviation experience. Experience in FDA / EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
  • Demonstrated experience with electronic system and databases.
  • Demonstrated proficiency in root cause analysis tools including but not limited to 5-WHY Human error prevention Ishikawa Diagram (Fishbone Analysis) Process Flow Diagram etc.
  • BMSCART

    #LI-ONSITE

    GPS2025

    If you come across a role that intrigues you but doesnt 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.

    Compensation Overview :

  • Devens - MA - US : $100480 - $121756
  • 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 employees 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 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 : T he 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 . Visit 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 : Protection

    We will never request payments financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

    Required Experience :

    Manager

    Key Skills

    Quality Assurance,FDA Regulations,Food Industry,Food Safety Experience,ISO 9001,Quality Systems,Food Processing,Quality Control,Quality Management,QA / QC,Selenium,HACCP

    Employment Type : Full-Time

    Experience : years

    Vacancy : 1

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