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Working with Us
Challenging. Meaningful. Life-changing. Those aren\\xe2\\x80\\x99t 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\\xe2\\x80\\x99ll 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.

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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.

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Bristol Myers Squibb Ireland

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Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units.

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Ireland is home to External manufacturing\\xe2\\x80\\x99s global headquarters, the business unit responsible for the management of manufacturing contract operations (CMO\\xe2\\x80\\x99s) and ensuring reliable supply of product to patients across the Bristol Myers Squibb global network.

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This includes management of, and working in conjunction with, third party contract manufacturers and internal manufacturing sites. In Ireland, External Manufacturing has two sites; Global Headquarters based in Dublin 15 and a distribution centre in Shannon, Co Clare.

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For more information about Bristol Myers Squibb, visit us at BMS.com/ie

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The Role

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BMS External Manufacturing is looking to recruit on a permanent Contract Director, Quality Operations, reporting to Senior Director, EXM Quality Non-Sterile and Packaging.

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Director, Quality Operations is to lead the quality and compliance oversight management of third party manufacturers engaged by External Manufacturing within a cross functional team. To ensure that the Quality resources working on the Virtual Plant Teams (VPT) are appropriate, effective and coordinated.

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Ensure compliant and timely QP certification of products manufactured/packed in relevant third party manufacturers in accordance with the conditions of the applicable manufacturing authorizations.

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Co-ordinate quality-impacting activities from cross-functional and global groups impacting on the VPT to ensure success of VPT objectives.

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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.

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Key Duties and Responsibilities:

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• Proactively manage Third Party Manufacturer and Alliance Partnership relationships from a quality and compliance perspective\\n
• Develop and manage the quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships\\n
• Actively support the BMS Fact Finding (FF) and Product Review Committee (PRC) processes for major investigations involving Third Party products. Prepare and present the information to senior management in support of the FF/PRC processes\\n

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• Provide quality/compliance subject matter expertise to the wider Supplier Relationship Management, Global Procurement, Supply Chain and MS&T teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs etc.\\n
• 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, regulatory agency questions etc.\\n

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• Manage the quality metrics programs in relation to Contract Manufacturing Organization and VPT performance\\n
• Assign the Quality Operations support for Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties\\n

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• Negotiate and approve Quality Agreements with the Third Party Manufacturers and Alliance Partners\\n
• Review and approve the Annual Product Quality Reviews submitted by the Third Party Manufacturers\\n

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• Support the Global BMS external auditing program\\n
• Select and retain Quality employees on VPTs\\n
• Allocate resources such that the right person is doing the right work at the right time\\n
• Review and approve goals and objectives for direct reports\\n
• Proactively develop and mentor staff\\n

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Qualifications, Knowledge and Skills Required:

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• In depth knowledge of cGMP regulations pertinent to the USA, EU and other international markets\\n
• Ability to assess the right balance between business targets and scientific and quality decisions\\n
• Ability to build relationships, partnerships and influence and/or enforce quality decisions at external manufacturers\\n
• Strong negotiation, communication and presentation skills across all levels both internal and external to BMS Strong analytical and problem solving skills\\n
• BSc or equivalent in scientific discipline\\n
• Minimum ten years experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency\\n
• 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\\n
• Direct experience interacting with Health Authorities and managing Health Authority inspections, specifically FDA and/or EMA\\n
• Direct experience in interacting with external manufacturers and managing quality at external manufacturing sites\\n
• The Qualified Person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products\\n

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Why you should apply

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You will help patients in their fight against serious diseases

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You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.

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You\\xe2\\x80\\x99ll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 23.5 days annual leave plus 3 Company days, access to BMS Cruiserath on-site gym, life assurance and gain-sharing bonus.

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BMSBL

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#LI-Hybrid

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If you come across a role that intrigues you but doesn\\xe2\\x80\\x99t 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.

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Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as \\xe2\\x80\\x9cTransforming patients\\xe2\\x80\\x99 lives through science\\xe2\\x84\\xa2 \\xe2\\x80\\x9d, 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.

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On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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