Manager, Quality Services

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. Bristol Myers Squibb Ireland Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus. BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020 and 2021. For more information about Bristol Myers Squibb, visit us at BMS.com/ie The Role BMS Cruiserath Biologics is seeking to recruit a for temporary 12 months contract Manager, Quality Services, reporting to Quality Services Leader. The Manager will 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). 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: 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. 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 3AQuality 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 TPCs and Alliance Partners. Qualifications, Knowledge and Skills Required: 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 BSc or equivalent in scientific discipline Greater than seven (7) 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 What’s important to us Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases: Passion: Our dedication to learning and excellence helps us to deliver exceptional results. Innovation: We pursue disruptive and bold solutions for patients. Urgency: We move together with speed and quality because patients are waiting. Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments. Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues. Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential. We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve. 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 an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus. BMSBL
LI-Hybrid 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.