Manager, Quality Services

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:

• BSc or equivalent in scientific discipline
• Greater than four (4) years’ experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, or Regulatory areas, or a position within a health Authority agency.
• Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables firsthand 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 FDA and/or EMA
• Direct experience in interacting with external manufacturers and supporting quality at external manufacturing sites
• In depth knowledge of cGMP / GDP regulations pertinent to the USA, EU and other international markets
• Ability to assess the right balance between business targets and scientific and quality decisions
• Strong analytical and problem solving skills
• Ability to build relationships, partnerships and influence and/ or enforce quality decisions at external / internal sites as appropriate
• Good communication and organizational skills
• Project management skills

THE ROLE

BMS External Manufacturing is looking to recruit on a Fixed Term Contract Manager, Quality Services, reporting to Director, External Manufacturing Quality Services.
Provide quality and compliance support to Quality Operations, Alliance Partners and Third Party Customers in External Manufacturing Quality.
Ensure that appropriate BMS GMP and regulatory standards are adhered to for products supplied by BMS sites and CMOs through External Manufacturing to Alliance Partners and Third Party Customers (TPMs).
Note: Occasional travel may be required as part of this role

KEY DUTIES AND RESPONSIBILITIES:

• Support 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 Active Pharmaceutical Ingredients (API) and Drug Products. 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 Contract Manufacturing Organizations (CMOs) managed by ExM.
• Provide quality/compliance support to the Quality Operations Managers
• Write, revise and review GMP documentation where necessary
• Co-ordinate/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.
• Prepare / negotiate Quality Agreements with the Third Party Manufacturers, Third Party Customers (TPCs), Alliance Partners and Marketing Authorisation Holders, including those associated with multiple CMOs / BMS parties
• Support the Quality Operations metrics programs in relation to Third Party performance.
• Support receipt of the Annual Product Quality Reviews (APQRs) from the Third Party Manufacturers – manage Quality Operations compliance with the APQR procedure
• Work with BMS sites to ensure that APQRs are provided to TPCs and Alliance Partners in a timely manner.
• Support gap analysis of site SOPs / quality directives / policies / global Health Authority (HA) observations as the SME for Quality Operations EMEA and ensure gaps are mitigated.
• Lead/Support 3B quality council activities, Support tier 2 Council, Regional Quality Council and Global Quality Council to ensure Quality Operations metrics are available from the CMOs; HA Inspection Tracking, MAFF Status, Significant Event Monitoring, deviation closure, etc.
• Provide general GMP / GDP HA inspection or Self Inspection support as required (preparation, back room, etc.).
• Manage the quality oversight for TPCs / Alliance partners.
• Build strong effective working relationships with TPCs and Alliance Partners.
• Manage the communication of change controls from BMS sites to TPCs and Alliance Partners and ensure review, approval and the requisite filing are completed by TPCs and Alliance Partners to support change in a timely manner
• Support the close out of complaints from a TPC or Alliance Partner through the appropriate BMS system and approve the outcome and CAPAs where required.
• Review any change proposals by TPCs or Alliance Partners.
• Provide the requisite quality support to Global BMS functional groups such as Global Regulatory / CMC and the local country based regulatory managers in support of regulatory filings, product renewals, and regulatory agency questions etc. for CMOs.
• Represent ExM Non-Sterile Packaging business unit on global quality teams/initiatives/projects and lead projects as needed
• Assist the exchange of regulatory information required for filing updates or HA renewal for products supplied to Third Party Customers and Alliance Partners.