Bristol Myers Squibb Associate Director, Quality Operations, Drug Product EMEA and Asia Pac in Dublin, Ireland
Bristol Myers Squibb (BMS) has one of the richest biopharmaceutical pipelines in the industry. We discover, develop, and manufacture lifesaving and life altering drugs in cancer, hepatitis C, heart disease, and other therapeutic areas. BMS also has one of the most reliable supply networks and our clinical operations program is among the best and busiest anywhere. We are a company that is forward thinking, a company in which diversity and inclusion are at the forefront of how we view our talent and how we work. Our science is second to none and the transformation work underway will enable us to continue to lead our peer group.
Bristol-Myers Squibb External Manufacturing is looking for a permanent Associate Director, Quality Operations, Drug Product EMEA and Asia Pac 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 priority Virtual Plant Teams (VPTs), or multiple VPTs are appropriate, effective and coordinated.
For specified products, perform QP release in accordance with the conditions of our manufacturing authorization.
A typical day might include the following:
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 MS&T 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 Contract Manufacturing Organization and VPT 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 Quality Reviews submitted by the Third Party Manufacturers
Support the Global BMS external auditing program by participation in audits of Third Parties as requested
Select and retain Quality employees on VPTs
Allocate resources such that the right person is doing the right work at the right time
Review and approve goals and objectives for direct reports
Proactively develop and mentor staff
This job might be for you if:
You hold a BSc or equivalent in scientific discipline and you have 10+ years’ experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency
You have 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
You have direct experience interacting with Health Authorities and managing Health Authority inspections, specifically FDA and/or EMA
You have direct experience in interacting with external manufacturers and managing quality at external manufacturing sites
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
You have an in depth knowledge of cGMP regulations pertinent to the USA, EU and other international markets
You have the ability to assess the right balance between business targets and scientific and quality decisions
You have the ability to build relationships, partnerships and influence and/or enforce quality decisions at external manufacturers
You have strong negotiation, communication and presentation skills across all levels both internal and external to BMS
You have strong analytical and problem solving skills
Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level.
The BMS Behaviours are: Passion, Innovation, Accountability and Speed.
Why should you apply:
You will help patients in their fight against serious diseases and you will increase the survival of more people with cancer
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 health insurance, 23.5 days annual leave plus 3 Company days, life assurance and gain-sharing bonus.
We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.