Associate Director, QA Methods & Compliance

☞ Bristol Myers Squibb

View: 284

Update day: 26-03-2024

Location: Boudry Neuchâtel NE

Category: Quality Assurance / Quality Control

Industry: Pharmaceuticals

Position: Associate

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.
  • Work in close collaboration with Global Process Owner and QRM team to ensure Level 2 processes remain in a state of control and are effective/efficient
  • Support process development, deployment, maintenance, monitoring and improvement of assigned QRM procedures
  • Identify and track progress against key project milestones partnering with applicable business, quality and other enabling functions and any external providers to ensure overall project success.
  • Drive process monitoring/adoption and GxP risk profiles through data collection, analysis, trending and reporting of QRM dashboards, and following up on non-compliances, risk trends, and continuous improvement
  • Support the design, development, testing and roll out of IT systems supporting QRM processes and data analytics.
  • Work effectively across the GxP Quality Management Systems network, engaging with broader Process Owner network and functional/site SMEs in order meet project milestones, and continuously improvement process adoption and enhancements
  • Participate/lead regulatory surveillance and Pharma Industry networking/benchmarking initiatives with peers internally and externally to ensure awareness of current regulations/guidance that impact QRM processes and identify/execute procedural enhancements as required
  • Lead/support QRM training development & deployment as per QRM training strategy
  • Support/lead QRM Community of Practices (CoPs) including sharing best practices, training/coaching and regular communication of QRM strategies/risk dashboards and process improvements
  • Support site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses
  • Support or manage high-priority, cross-functional initiatives
  • Maintain awareness of Culture of Excellence across BMS
  • Provides site and functions training, guidance and support as needed
  • Ensure compliance with regulatory requirements relating to investigation, company policies and procedures
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.

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 any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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Deadline: 10-05-2024

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