Senior Manager, Quality Services, ExM Bio/Sterile

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 .

Required Qualifications and desired experience

• Equivalent to 8 years’ experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, or Regulatory areas, or a position within a health Authority agency.
• Bachelor of Science (BSc) or equivalent in scientific discipline.
• 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.
• Direct experience interacting with Health Authorities and supporting Health Authority inspections, specifically the Food and Drug Administration (FDA) and/or European Medicines Agency (EMA).
• Direct experience in interacting with external manufacturers and supporting quality at external manufacturing sites

BMS External Manufacturing is looking to recruit a fix term Senior Manager, Quality Services, ExM Bio/Sterile who will provide quality services and compliance support to Quality Operations in External Manufacturing Quality, ensure that appropriate Bristol Myers Squibb (BMS) Good Manufacturing Practices (GMP) and regulatory standards are adhered to for products supplied by BMS sites and Contract Manufacturing Organisations (CMOs) through External Manufacturing.

Key Responsibilities

• Lead Site Quality Council and support GxP /Pillar Quality Council to ensure Quality Operations metrics are available from BMS Systems and the CMOs; Health Authority (HA) Inspection Tracking, Market Action Status, Significant Event Monitoring, deviation closure, etc.
• Drive attainment of the Quality Operations KPI metrics and performance improvement
• Raise Notifications to Management (NTMs) where required for major and critical investigations.
• Lead the BMS Fact Finding Information Team (FIT) and Fact Finding Information Review Meeting (FIRM) processes and support the Product Review Committee (PRC) process for major investigations involving third Party BioSterile manufacture. Prepare and present the information to senior management in support of the FIT / FIRM processes.
• Support the Product Action Committee (PAC) process for all recalls associated with CMOs managed by ExM.
• Support issuance of HA notifications (e.g. Field Alert Reports) where required.
• Lead Global Regulatory Observation evaluation (GROe) Assessments on behalf of ExM BioSterile.
• Provide quality/compliance support to the Quality Operations Managers
• Lead Continuous Improvement and/or Compliance projects supporting the External Manufacturing (ExM) or network.
• Coordinate/track the annual CMO Risk Assessment (RA), ensuring timely completion of the assessment.
• Support Quality Risk Mitigation Plans for CMOs based on the annual RA and any other interim triggers, and monitor their implementation.
• Management of the Quality Agreement process.
• Drive adherence to Annual Quality Agreement Plan for TPMs, Third Party Customers (TPCs), Alliance Partners and Marketing Authorisation Holders (MAHs), including those associated with multiple CMOs / BMS parties.
• Prepare / negotiate Quality Agreements with the CMOs, internal sites and MAHs, including those associated with multiple CMOs / BMS parties.
• Manage the quality oversight for TPCs / Alliance partners & Build strong effective working relationships with TPCs and Alliance Partners.
• Support receipt of the Annual Product Quality Reviews (APQRs) from the CMOs - drive Quality Operations compliance with the APQR procedure.
• Support gap analysis of site standard operating procedures (SOPs) / quality directives / policies / global Health Authority (HA) observations as the Subject Matter Expert (SME) for Quality Operations Europe, the Middle East and Africa (EMEA) and ensure gaps are mitigated.
• Represent the tower during HA inspections including inspection preparations.
• Provide general GMP / Good Distribution Practice (GDP) HA inspection or Self-Inspection support as required (preparation, back room, etc.).
• Support the bona fide process as required.
• Represent ExM BioSterile business unit on global quality teams/initiatives/projects and lead projects as needed.
• Write, revise and review GMP documentation where necessary.

Required competencies

• In depth knowledge of current Good Manufacturing Practices (cGMP) / GDP regulations pertinent to the United States of America (USA), European Union (EU) and other international markets.
• Ability to assess the right balance between business targets and scientific and quality decisions.
• Operational Excellence and Project Management skills.
• Information technology (IT) systems knowledge and ability to extract and analyse data from multiple sources.
• Strong analytical, problem solving and problem-solving skills.
• Ability to build relationships, partnerships and influence and/ or enforce quality decisions at external / internal sites as appropriate.

Required Qualifications and desired experience

• Equivalent to 8 years’ experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, or Regulatory areas, or a position within a health Authority agency.
• Bachelor of Science (BSc) or equivalent in scientific discipline.
• 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.
• Direct experience interacting with Health Authorities and supporting Health Authority inspections, specifically the Food and Drug Administration (FDA) and/or European Medicines Agency (EMA).
• Direct experience in interacting with external manufacturers and supporting quality at external manufacturing sites.

Note: Occasional travel may be required as part of this role

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 of annual leave , access to BMS Cruiserath on-site gym and life assurance.