Senior Manager, Quality Operations, Drug Product, EMEA and Asia Pacific

5 days ago

Dublin, Dublin City, Ireland Bristol Myers Squibb Full time

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 Ireland

Bristol Myers Squibb (BMS) has been in operation in Ireland since 1964, employing over 600 people across a range of activities and business units.

The Global External Manufacturing (ExM) organization headquartered in Dublin, is responsible for the management of manufacturing and reliable supply across the Bristol Myers Squibb global network. 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 HQ in Dublin 15 and a distribution centre in Shannon, Co Clare.

Many of the global business services, including Commercial, the European Treasury Centre, Global Bio Lab and Global Logistics are based on the island of Ireland. Ireland is also home to Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility. This state of the art facility produces multiple therapies for the company's growing biologics portfolio and plays a central role in Bristol Myers Squibb global manufacturing network.

ExM's strategy and robust operating model is focused on evolving and continuously improving ways of working to take External Manufacturing to the next level, leveraging data and technology in an effort to deliver product to customers and patients at optimum speed, time and cost.

The Role

BMS External Manufacturing is looking to recruit a  Senior Manager, Quality Operations ,Drug Product, EMEA and Asia Pacific . Quality Operations Senior Manager will provide quality and compliance oversight management to third party manufacturers engaged by External Manufacturing within a cross functional team

Key responsibilities will include, but not limited to:

Proactively manage Third Party Manufacturer and Alliance Partnership relationships from a quality and compliance perspective Develop and manage the quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships 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 Provide quality/compliance subject matter expertise to the wider Supplier Relationship Management, Global Procurement, Supply Chain and MT teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs etc. 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. Manage the quality metrics programs in relation to Third Party 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 with the Third Party Manufacturers and Alliance Partners Review and approve the Annual Product Reviews submitted by the Third Party Manufacturers Support the Global BMS external auditing program by participation in audits of Third Parties as requested

Qualifications, Knowledge and Skills Required :

The successful candidate will hold a BSc or equivalent in scientific discipline Five to ten years' experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency Direct experience interacting with Health Authorities and managing Health Authority inspections, specifically FDA and/or EMA Direct experience in interacting with external manufacturers and managing quality at external manufacturing sites 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 cGMP regulations pertinent to the USA, EU and other international markets Ability to assess the right balance between business targets and scientific and quality decisions 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. 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 only, an annual bonus, pension contribution, family health insurance, 27 days of annual leave , access to BMS Cruiserath on-site gym and life assurance

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