Manager Quality Operations – Bristol Myers Squibb – Boudry, NE

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.

Working in a cross-functional virtual plant team this quality associate manager provides quality oversight of Contract Manufacturing Organizations (CMOs). Primary responsibility is to support management of CMO disposition documentation, assure CMO compliance with BMS and applicable cGMP and international regulatory standards for biologics drug substance and drug product manufacture, testing, and distribution.


Key Accountabilities:

  • Perform product disposition activities to ensure the timely supply of drug substance, drug product, and finished product that meet commercial customer requirements while ensuring compliance with testing standards, SOPs, validation guidelines and regulatory filings.
  • Author, compile and maintain documentation needed for disposition of the product from Contract Manufacturing Organizations (CMOs)
  • Review disposition documentation from CMOs and recommend disposition, escalating potential issues
  • Ensure batch documentation relative to CMO materials and products is maintained and archived
  • Input required deviation, complaint, change control, and product disposition information into applicable enterprise systems
  • Prepare and review of Quality Agreements with external manufacturers and external laboratories
  • Manage quality metrics in relation to CMO performance
  • Prepare Annual Product Quality Reviews as required for end to end product monitoring
  • Work with CMOs to ensure PAI readiness plans are appropriate, and corrective actions are tracked to completion
  • Assist with reviewing analytical and method protocols and reports for compliance
  • Assists analytical lead for method test transfer and revision documentation
  • Provide quality support during self-inspections, internal audits, and regulatory agency inspections at contract manufacturers.
  • Support supplier relationship manager, global procurement, supply chain and manufacturing science and technology teams for new projects, technical transfers programs, supplier selection programs, and commercial manufacturing activities
  • Review validation documents, deviations, and change controls and escalate any potential compliance gaps
  • Escalate issues to senior management to ensure that issues are resolved to support BMS business and compliance requirements
  • Evaluate external quality complaint investigations provided by CMOs


Required:

  • Minimum B.S. degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science
  • Minimum of 4 years’ experience in pharmaceutical operations at the manufacturing site
  • At least 2 years in Quality, ideally in product release or pharma project quality
  • Experience in aseptic, sterile and biological drug product manufacturing
  • Experience in contract manufacturing or contract testing
  • Good verbal, written and presentation skills in English
  • Good knowledge of German (allowing for the review of technical documentation)
  • Experience with technical writing, ideally with authoring investigations, quality risk assessments, process descriptions, or study protocols


Ideal Candidates Would Also Have:

  • Ability to negotiate and clearly present complex topics both in written and verbally
  • Knowledge of combination products manufacturing or finished drug product packaging
  • experience with biological product testing methods/quality control
  • Experience with GMP tools and standard applications: SAP, Trackwise or Verity, MS Office (esp. OneNote, Visio)
  • d stands for diverse, meaning that BMS welcomes every employee independent of gender, age, sexual orientation, ethnicity, religion

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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