Quality Operations External Manufacturing Manager
vor 3 Wochen
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 manager provides quality oversight of Contract Manufacturing Organizations (CMOs). Primary responsibility is to support management of CMO disposition documentation, assure CMO compliance with Bristol Myers Squibb (BMS) and applicable current Good Manufacturing Practices (cGMP) and international regulatory standards for biologics drug substance and drug product manufacture, testing, and distribution.
**Responsibilities**
- Perform product disposition activities to ensure timely supply of drug substance, drug product, and finished product that meet commercial customer requirements while ensuring compliance with testing standards, standard operating procedures (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 and report quality metrics in relation to CMO performance
- Prepare and review Annual Product Quality Reviews for BMS products at CMOs as required
- Work with CMOs and BMS project teams to ensure pre-approval inspection (PAI) readiness and filing submission readiness for the new products transferred to CMOs or major process changes.
- Assist with reviewing analytical and method protocols and reports for compliance
- Assist with commercialization quality-related activities on the new products transferred or launched to/from CMOs
- 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
- Ensure maintenance of System, Applications and Products (SAP) Master Data (related to Quality)
**Qualifications, Knowledge and Skills Required**
- Minimum B.S. degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science
- Minimum of four (4) years’ experience in pharmaceutical operations at the manufacturing site
- At least two (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
- Experience with technical writing, ideally authoring investigations, quality risk assessments, process descriptions, or study protocols
- 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
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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