Associate Director, Quality Operations, Bio/Sterile

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.

Quality Operations lead role within External Manufacturing Quality. Manages external CMOs who perform Biologic Drug Substance and Sterile Drug Product manufacturing. Leads a team of Quality professionals. Provides Quality oversight and ensures compliance. Duties include Batch Release, Investigations, managing Quality Systems (Change Control, Complaints, APQRs) and manages Quality Agreements with CMOs. Manages risk and utilises QRM methodologies. Supports Audits and Health Authority inspections at CMOs and embeds regulatory surveillance ensuring CMOs are meeting HA expectations and requirements.

Responsibilities

• Lead, coach and develop a team of Quality Managers to ensure all cGMP and GDP aspects required to support a Bristol Myers Squibb (BMS) VPT are met, covering clinical, commercial as well as project-related activities for Drug Substance, Drug Product and Drug/Device combination products, as applicable.
• Represent ExM Quality in project teams to provide quality/compliance subject matter expertise and guidance to the wider Supplier Relationship Management, Global Procurement, Supply Chain and Manufacturing Science and Technology (MS&T) teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs.
• Partner with the Quality Services function to develop and maintain the quality system at GCH.
• Manage quality events, change controls and market complaints in cooperation with BMS internal teams as well as with Third Party Manufacturers.
• Actively support the BMS investigation teams, escalation and recall events, as well as BPDR, MDR, FAR submission processes for major investigations involving CMO products. Prepare and present the information to senior management in support of above processes.
• Manage the quality metrics programs in relation to CMO performance.
• Perform preparation, review and revision of applicable Quality Agreements to support manufacture and testing of BMS products at CMOs.
• Review and Approve Annual Product Quality Reviews as required for end-to-end product monitoring.
• Perform batch package review activities in alignment with BMS operations functions to ensure compliance with testing standards, standard operating procedures (SOPs), validation guidelines, regulatory filings and cGMP and GDP requirements in preparation of batch release with a view to ensure the timely supply of drug substance and drug product, as applicable.
• Review, provide input and approve CMO batch-related records, validation reports, deviations and change controls.
• Directly interface with CMO Quality Assurance (QA) management regarding any potential compliance gaps, deviation resolution and regulatory inspections.
• Partner with the External Manufacturing group to provide effective oversight of manufacturing operations at CMOs.
• Work with CMOs, vendors and analytical laboratories to evaluate their audit and inspection readiness and work with these groups to ensure that appropriate corrective actions are made to support BMS expectations and successful inspectional outcomes.
• Escalate issues to CMO Senior Management to ensure that issues are resolved to support BMS business and compliance requirements.
• Represent BMS Quality during any regulatory agency inspections of the CMO site and ensure timely responses to any issues which may be identified.
• Lead Quality Council meetings with the CMO and provide regular communication and progress reports to BMS management.
• Lead or contribute to Operational Excellence projects.
• Escalate issues to BMS Senior Management as per valid processes to ensure that issues are resolved to support BMS business and compliance requirements
  

Required Competencies

• Strong strategic and analytical thinking, problem-solving and rapid decision-making skills.
• Demonstrated capability in achieving challenging goals
• Strong ability in negotiating and influencing without direct authority in complex, high impact situations
• Demonstrated ability in technical writing, Information Technology application of knowledge and communication skills is required.
• Strong presentation and communication skills both oral and written
• Team Management experience is required
  

Qualifications

• Minimum B.S degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy or related Sciences
• Minimum of 10 years experience in bio-pharmaceutical operations, with at least 7 yrs in Quality Assurance commercial (and also ideally development/clinical)
• Demonstrated experience working in an External Manufacturing operation set up (mandatory)
• Relevant experience in Aseptic manufacturing and microbiology practices
• Hands-on experience in Quality Operations with batch release experience for drug products and finish products
• Strong expertise and knowledge in Global GMP regulations (including FDA and EU) and emerging requirements for Biologics and Sterile Products
• Fluent in English and preferably in German
• This position is based in Switzerland at the BMS Boudry site and works within a cross-functional International team. Travel is required (25%).
  

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.