Bristol Myers Squibb Quality Operations Manager 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 Quality Operations Manager within the Global Quality External Manufacturing department.
The Quality Operations Manager will be responsible for the Quality oversight of manufacturing, packaging, testing and release activities at Contract Manufacturing sites.
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.
Quality management oversight of the warehouse GMP/GDP activities (if you will be based in our Shannon office).
Where applicable as a Qualified Person on the manufacturing and importation authorization: to act as one of the company’s Qualified Persons in accordance with EU directive 2001/83/EU.
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.
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.
Exhibits BMS BioPharma Behaviors.
Strong analytical and problem solving skills.
Qualifications and Desired Experience:
5 - 10 years' experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency.
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.
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.
Please note standard travel for this role is approx. 20%
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.