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Manager, Quality Assurance

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Job Description - Manager, Quality Assurance

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.

Product Development Quality (PDQ) Good Manufacturing Practice (GMP) ensures quality and compliance for clinical supplies. We oversee manufacturing, testing, and distribution, certify products for UK/EU, audit processes and suppliers and support teams with regulatory expertise, from routine guidance to inspection readiness.

Position Purpose

Performs specific quality related functions such as Quality/GMP training, materials/products releasing, quality incident investigations to ensure compliance with GMP regulations and Bristol Myers Squibb (BMS) standards.

People management is not required for this role.

Key Responsibilities

  • Reviews all batch and test documentation associated with investigational medicinal products (IMPs), APIs, raw materials and packaging components.
  • Supports in the investigation of non-conformances and quality incidents. 
  • Resolves and documents any deviation or problem pertaining to the audit of documents. 
  • Conducts appropriate follow-up. 
  • Tracks and trends deviation investigations and CAPA.
  • Reviews and approves documents related to Quality Systems such as master batch records, validation protocols/reports, change control, or SOP/WI/OIs to support the release function.
  • Conduct GMP Training for functional areas supported and provides on-the-job training to new Quality Operations employees
  • Participate in Vendor/ Contractors Qualification activities
  • Reviews procedural documents
  • Participates in the monitoring program
  • Support internal and/or external audits

Knowledge, Skills & Experience

  • Experience in a Quality Assurance role within the pharmaceutical industry.
  • Experience in dealing with regulatory agencies.
  • Knowledge of pharmaceutical development process.
  • In-depth knowledge of GxP regulations.
  • Effective report writing ability.
  • Computer literacy (Microsoft Office and SAP environment).
  • Experience in a R&D environment

#LI-Hybrid

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.

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

Bristol Myers Squibb is Disability Confident – Employer

A UK Government scheme

Candidate Rights

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

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 [email protected]. 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.

R1598051 : Manager, Quality Assurance
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