Manager, Regulatory Compliance and Operations

☞ Bristol Myers Squibb

View: 158

Update day: 29-03-2024

Location: Boudry Neuchâtel NE

Category: Finance / Bank / Stock Sales

Industry: Pharmaceutical Manufacturing

Position: Mid-Senior level

Job type: Full-time

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Job content

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 External Manufacturing Quality Organisation is seeking to recruit a Manager, Regulatory Compliance and Operationswho will report directly to the Associate Director, Regulatory Complianceand will be responsible for all regulatory support activities within External Manufacturing.Key Responsibilities Will Include, But Not Limited To
  • Working as part of a team dealing with global market registrations and providing regulatory compliance/operations guidance, and support to all External Manufacturing groups.
  • Coordination of EXM quality dossier (Module 2 and 3) review process for Pharmaceutical and Biologics products at all nodes of the supply chain for new product introductions, and post approval variations including but not limited to new manufacturing facilities and process changes.
  • Point of Contact for requests to source and provide relevant regulatory documentation (e.g. SOPs, Technical Reports, CoA’s, Analytical raw data) to support regulatory requests for post approval variations, renewals, and annual reports.
  • Support product release by managing appropriate systems to ensure product market compliance to enable seamless release of finished product to the market.
  • Review of local and global change controls, deviations, CAPA’s, technology transfer plans, and regulatory submission plans.
  • Maintains strong communication and working relationships with all departments, contract manufacturing organizations, and global personnel such as CMC.
  • Participating in other QA supporting activities as required (e.g. internal audits, site regulatory inspections, APQR’s, quality risk management).
Qualifications, Knowledge And Skills Required
  • The successful candidate will have a minimum of 3 years Quality/Compliance/Technical experience in a biopharmaceutical operations role.
  • Biologics regulatory experience and familiarity with regulatory dossier sections (Module 2 and 3) would be advantageous.
The Candidate Should Be Able To Demonstrate
  • Ability to work independently and within team matrix environments.
  • Ability to manage teams associated with individual aspects of responsibilities, direct people management and project management aspects.
  • Thorough knowledge of worldwide regulatory Good Manufacturing Practices (GMP) requirements and a working knowledge of Food and Drug Administration (FDA) & European Union (EU) GMP requirements.
  • In depth knowledge of Quality Management Systems with an emphasis on change control principles and the applicability of restriction/regulatory holds in the release process for changes that require health authority approval.
  • Ability to assess the right balance between the business implications, technical considerations and quality decisions.
  • Excellent organisational and administration skills are required in addition to strong interpersonal skills.
  • The successful candidate must be able to prioritise, organise and manage multiple tasks to tight deadlines.
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.
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Deadline: 13-05-2024

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