Senior Manager API Quality Operations

3 weeks ago

Dublin, Dublin City, Ireland Bristol-Myers Squibb Full time

Senior Manager API Quality Operations

Senior Manager API Quality Operations

Apply locations Dublin - IE time type Full time posted on Posted 2 Days Ago job requisition id R1589237

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.

The Role

BMS External Manufacturing is looking to recruit a fixed-term Senior Manager API Quality Operations to 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.

Key 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.
  • Manage 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.
  • Carry out batch release as required.

Note: Travel will be required on a routine basis as part of this role (approx. 10-15%).

Minimum Qualifications:

  • Minimum a BSc, preferably with a postgraduate qualification and minimum 5 years´ experience in a GMP manufacturing environment. Operational Excellence (OpEx) experience desirable.
  • 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 limited to, an annual bonus, pension contribution, family health insurance, 27 days of annual leave, access to BMS Cruiserath on-site gym and life assurance.

#LI-Hybrid

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

#J-18808-Ljbffr

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