Senior Manager, Quality Operations
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Sr. Manager, Quality will provide Quality oversight to the CMO with the ability to travel and be on site a minimum of 50% (as required). You will manage CMO oversight for change management, deviation management, Annual Product Quality reports, Quality Agreements, Risk Assessments and CMO product release. This position may also be cross trained to cover other QA functions as needed.
- Assists with preparation for FDA and other regulatory agency audits and inspections. Provides daily summaries and follows the completion of CAPAs from audit findings.
- Provides oversight for CMO Batch Production Records. Review executed Batch Records, GMP documents and prepare documentation for product release/disposition.
- Gives guidance to CMO as needed and ensure CMO is compliant with BMS Quality standards.
- Understands practical applications of Quality Systems (SAP, Infinity, DCA, etc).
- Assists with Document Control and other QA functions.
- Maintains Good Manufacturing Practice (GMP) at company through shop floor evaluations and review of related documentation during manufacturing execution activities.
- Ensures that all audit items are resolved. Supports site for Inspection. Reviews any Quality Events, CAPAs from internal and external audits to ensure that actions necessary to provide adequate confidence that the GMP requirements are completed on time.
- Coordinates and assist in timely review of Commercial Material manufactured at CMO site.
- Escalates critical quality problems to Senior Management in a timely manner.
- BS in Life Sciences or equivalent with 10+ years related experience within a pharmaceutical or Biotechnology Company.
- Hands-on QA Operations and QA Systems experience including supporting Validations within pharmaceutical or Biotechnology Company. Must be fluent in English language.
- Additional experience in an area allied with cGMP Quality, Quality Systems, Biopharma Production Processes, 21CFR 210-211, ICH guidelines, FDA Guidance for Industry for Investigating OOS Results, Deviations, CAPAs, Validation, Stability Studies, QC laboratory operations and manufacturing operations, auditing is preferred.
- Ability to Coordinate Quality oversight and working with other site groups.
- Ability to review Quality documents and ensure compliance to GMP and alignment with BMS policies. Documents to include batch records, logbooks, Annual Product Quality reports, and other associated documentation to support batch disposition.
- Ability to be an effective communicator to Management, and line staff.
- Ability to work with other manufacturing teams to implement business
- Must be very detail oriented
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.