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Job Details


Bristol Myers Squibb

Senior Manager, PDQ Compliance and Quality Systems

Agriculture and Forestry

Agricultural Manager

No

New Brunswick, New Jersey, United States

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.

We are seeking a Senior Manager to lead and provide compliance support for Product Development (PD) in the areas of Risk Management, Investigations and Global Regulatory Observation evaluations. This will include ensuring compliance and inspection readiness by conducting self inspections, supporting internal audits and being accountable for metrics generation and communication at the Tier 2 Quality Council.

Responsibilities will include:

  • Lead the PD Quality Risk Management (QRM) Community of Practice. Create/Publish/Maintain the PD QRM Master Plans and Risk Registers for all 4 PD sites; risk facilitation

    Lead the Global Regulatory Observation evaluations for PD

    Participate in the Investigations Excellence Team; qualify as a Lead Investigator

    Conduct and/or Lead PD self inspections

    Coordinate meetings, collate and communicate metrics through the Tier 2 Quality Council

    Supports site operations during regulatory agency and third party inspection

  • Adherence to BMS core behaviors

Basic Qualifications:

  • BA/BS and 10+ years of experience
  • MA/MS and 8+ years of experience

Preferred Qualifications:

  • B.S. or M.S. in chemistry, pharmacy or biology or a related pharmaceutical science
  • 3+ years experience in a regulated function in pharmaceutical quality and/or operations at a site level
  • Experience within a QA/QC environment is an asset
  • Broad experience in the manufacturing , packaging and labeling of sterile and non-sterile products
  • In-depth knowledge of GMP regulations
  • Strong collaborative and influencing skills
  • Expert skills with Microsoft Office and SAP environment Veeva® and other systems as required (eg DeltaV, Pilotclean)

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.