Sr Specialist, QA Investigations

Bristol Myers Squibb EU Policy; South Hadley Falls (MA); On-site; USD 84,000 - 102,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

Wellbeing support

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, QA Investigations to provide quality oversight of deviation investigations and CAPA programs at the Summit Cell Therapy Facility in NJ. The role ensures compliance with FDA/EMA guidelines and company policies while guiding cross-functional teams on root-cause analyses and corrective actions.

The role involves reviewing technical reports, facilitating inspection readiness, and mentoring teams.

Qualifications

• Bachelor's degree in STEM preferred; high school diploma/Associate with equivalent experience may be considered.
• 4+ years in a regulated industry with 1+ year deviation experience.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing preferred.
• Demonstrated experience with electronic systems and databases.

Responsibilities

• Review and approve investigations/CAPAs/effectiveness checks at the manufacturing site.
• Review and approve technical reports including risk assessments and deviation system monitoring reports.
• Ensure corrective/preventive actions and effectiveness check plans address root causes.
• Perform routine reporting and analysis of metrics to ensure timely closure of quality events.
• Identify improvement opportunities and support site/team continuous improvement.
• Support internal and external inspections as required.
• Maintain compliance with learning plans and support training delivery.
• Lead meetings and represent function at cross-functional meetings.
• Build and maintain relationships with partner functions.

Skills

Policies interpretation

MS Office

Smartsheets

Data interpretation

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in STEM

High school diploma/Associate degree with experience

Tools

MS Office

Smartsheets

Electronic systems & databases

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

The Senior Specialist, QA Investigations, is responsible for quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records at the Summit 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.

Shift Available

• Monday - Friday, Onsite Day Shift, 8AM - 5PM

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.
• 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 and Effectiveness Check plans are robust and adequately addresses 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.

Qualifications

• 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.

Education/Experience/ Licenses/Certifications

• 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.

Compensation Overview

Summit West - NJ - US: $83,900 - $101,671

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

• Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
• U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: 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 this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1606817 : Sr Specialist, QA Investigations