BristolMyers Squibb

Senior Specialist, Quality Assurance Investigations, Cell Therapy, Devens - MA

BristolMyers Squibb • $89K — $108K *
Devens, MA 01434In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in STEM field preferred; alternative education or experience will be considered.
  • 4+ years of experience in a regulated industry, with at least 1 year in deviation investigations.
  • Familiarity with FDA/EMA regulations, particularly in biopharmaceuticals or cell therapy manufacturing.
  • Proven experience with electronic systems and databases used in quality assurance.
  • Experience in root cause analysis tools (e.g., 5-WHY, Ishikawa Diagram, etc.).

Responsibilities

  • Review and approve CAPAs and effectiveness checks for various manufacturing aspects.
  • Author, review, and approve technical reports supporting the deviations program.
  • Ensure corrective actions sufficiently address root causes of quality issues.
  • Perform routine metrics reporting to track the closure of quality events.
  • Identify improvement opportunities and support continuous improvement initiatives.
  • Assist in internal and external inspections as needed.
  • Develop and deliver training content for cross-functional teams.

Benefits

  • Comprehensive health coverage including medical, dental, and vision care.
  • Access to wellbeing support programs and employee assistance services.
  • Financial protection offerings such as 401(k), disability and life insurance.
  • Flexible paid time off policies including unlimited time for U.S. exempt employees and additional national holidays.
  • Additional leave options including medical, parental, and bereavement leaves, and an annual Global Shutdown.
Full Job Description
The Senior Specialist, 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.

Responsibilities:
  • Review and approve investigations/ CAPAs / effectiveness checks associated with the manufacturing site including but not limited to materials, manufacturing, laboratory, facility, and computer systems.
  • May 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. Identifies improvement opportunities and supports execution of site/team continuous improvement goals and projects.
  • Support internal and external inspections as required.
  • Maintain compliance with assigned learning plan. Support development and delivery of training content to cross functional teams.
  • Lead meetings and represent function at cross functional meetings. Share data/ knowledge within and across team. Build & maintain strong relationships with partner functions.


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.
  • Ability to interpret data & results, understand problems with few variables and critically assess and provide feedback on proposed CAPA.
  • Ability 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 changing priorities.
  • Detail oriented and task focused with ability to meet deadlines and support work prioritization.
  • Able to work across functional groups and teams to ensure requirements are met.
  • Self-motivated and contribute to a positive team environment.
  • Confident in making decisions for minor issues and able to recognize Quality issues and solve problems.
  • Curious and ability to think critically to create innovative solutions.


Minimum Requirements:
  • Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
  • 4+ years of experience in a regulated industry with 1+ year deviation experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
  • Demonstrated experience with electronic system and databases
  • Demonstrated experience in root cause analysis tools including but not limited to 5-WHY, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, 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.

Compensation Overview:

Devens - MA - US: $89,780 - $108,789

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.

About BristolMyers Squibb

BristolMyers Squibb Careers

Join the vibrant team at BristolMyers Squibb, a leader in global biopharmaceutical innovation, where your career growth is as important as the life-changing solutions we develop. At BristolMyers Squibb, we are committed to fostering a diverse and inclusive workplace that encourages professional growth and development. Work You’ll Do Embark on a career with BristolMyers Squibb and be part of a company that’s dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With us, you’ll contribute to a culture that embraces scientific innovation, responsible leadership, and community outreach. Explore job opportunities in various fields from research to marketing, and join a team that values leadership and diversity. Our commitment to career growth means we support your journey with extensive training programs, leadership development opportunities, and a global, diverse network of professionals. Innovative Work At BristolMyers Squibb, innovation is at the core of everything we do. From pioneering research in oncology to breakthroughs in immunology, our professionals have the opportunity to make significant contributions to the field and impact lives globally. Our collaborative environment encourages team members to challenge the status quo and bring forward ideas that pave the way for groundbreaking solutions. Be Part of a Great Team Working at BristolMyers Squibb means being part of a team that supports your aspirations and shares your values. Our culture thrives on teamwork, respect, and diversity, creating a workplace where everyone can achieve their potential. Enjoy the benefits of being part of a company that values work-life balance, provides competitive benefits, and fosters an environment where skills and leadership are developed through hands-on experience and comprehensive mentorship programs. Future-Proof Your Career With a multitude of job opportunities ranging from internships to full-time positions, BristolMyers Squibb is not just hiring; we’re building futures. We equip our employees with the tools needed for success, including advanced training in diverse skill sets, leadership programs, and opportunities for professional networking and growth. Stay Connected Join Our Team Search open positions that match your skills and interests. We are looking for passionate, curious, and innovative team players who are ready to make a difference. Explore our career portal for all current job listings and be sure to submit your resume. Keep Up to Date Stay informed with the latest company news, career tips, and industry insights from BristolMyers Squibb. Our careers blog is a resource for potential and current employees looking to maximize their career potential. Job Alert Emails Customize your subscription to receive job alerts and insider information tailored to your preferences. Discover the exciting and rewarding career opportunities that await at BristolMyers Squibb. At BristolMyers Squibb, your career is just the beginning – it’s a pathway to personal and professional fulfillment. Join us and make a global impact.
Learn more about BristolMyers Squibb
Size
32,200 employees
Market Cap
$156.3 billion
Industry
Pharmaceuticals & Biotech
Net Income
-$9 billion
Founded
1887
5 Year Trend
+19%
Revenue
$42.5 billion
NASDAQ
BMY
* Ladders Estimates

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