Senior Manager, Quality Operations

at  BristolMyers Squibb

WORKING WITH US

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us .

Qualifications, Knowledge and Skills Required:

• Five years’ experience in the pharmaceutical industry, specifically in API manufacture, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency.
• Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables first-hand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences, and interface with research & development.
• In depth knowledge of current Good Manufacturing Practices (cGMP) regulations pertinent to the United States of America (USA), European Union (EU) and other international markets.
• Ability to build relationships, partnerships and influence and/or enforce quality decisions at external manufacturers.
• Strong negotiation, communication and presentation skills across all levels both internal and external to BMS.
• Exhibits BMS BioPharma Behaviors.
• Strong analytical and problem solving skill

BMS External Manufacturing is looking to recruit permanent Senior Manager, Quality Operations, reporting to the Associate Director, Quality Operations. The person covering this position will provide quality operations and compliance oversight management to Active Pharmaceutical Ingredient and intermediate contract manufacturing organisations (CMO) engaged by External Manufacturing within a cross functional team.
Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs.

Key Duties and Responsibilities:

• Proactively manage contract manufacturer relationships from a quality and compliance perspective. Build strong effective working relationships with CMO’s
• Quality lead for a Virtual Plant Team (VPT) or managing a significant portfolio at a CMO
• Develop and manage the quality events, change control and market complaints programs in respect of contract manufacturers. Ensure an effective deviation management system is in place to deal with vendor non-conformances from third party suppliers. Review process validation protocols and reports and also process verification/campaign reports for CMO’s where relevant.
• Ensure Quality by Design (QbD) principles are implemented for all new products at CMO’s. Review and approval of process risk assessment, process verification reports for CMO’s for intermediates and Active Pharmaceutical Ingredient (API). Support pre-approval inspections
• Manage all activities associated with vendor approvals
• Provide quality/compliance subject matter expertise to the wider Supplier Relationship Management, Global Procurement, Supply Chain and Manufacturing Science & Technology (MS&T) teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs, etc.
• Provide the requisite quality support to Global Bristol Myers Squibb (BMS) functional groups such as Global Regulatory/Chemistry Manufacturing and Controls (CMC) and the local country based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions, etc.
• Manage the quality metrics programs in relation to CMO performance
• Serve as the Quality Operations Leader in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties
• Prepare, negotiate and approve Quality Agreements and purchase specs with CMO’s
• Review and approve the Annual Product Reviews submitted by the CMO’s Support the Global BMS external auditing program by participation in audits of Third Parties as requested
• Mange information/provide information for quality council meeting
• Assess and implement corporate policies and directives
• Liaise with auditors of external vendors and suppliers. Review vendor audits to identify trends. Manage audit observation closure.
• Review and update CMO Bona Fides as required
• Carry out annual risk assessments for CMOs
• Review and update stability protocols as necessary
• Proactive management of direct reports as necessary
• Review and approving goals and objectives for direct reports
• Proactively manage the development of direct reports
• Carry out batch release as required
• In the absence of the Quality Associate Director / Director , Quality Operations Global API, the Quality Operations Senior Manager can act as designee:
• Review and approval of change controls
• Signatory on Good Manufacturing Practices (GMP) documentation
• Representation at meetings

Note * : Travel will be required on a routine basis as part of this role (approx. 25%).

Qualifications, Knowledge and Skills Required:

• Five years’ experience in the pharmaceutical industry, specifically in API manufacture, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency.
• Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables first-hand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences, and interface with research & development.
• In depth knowledge of current Good Manufacturing Practices (cGMP) regulations pertinent to the United States of America (USA), European Union (EU) and other international markets.
• Ability to build relationships, partnerships and influence and/or enforce quality decisions at external manufacturers.
• Strong negotiation, communication and presentation skills across all levels both internal and external to BMS.
• Exhibits BMS BioPharma Behaviors.
• Strong analytical and problem solving skills

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance.