Bristol Myers Squibb Quality Operations Senior Specialist in Dublin, Ireland
Bristol-Myers Squibb External Manufacturing are looking to hire a Quality Operations Senior Specialist to support the Quality Projects group within the EMEA region. In this role, the candidate will provide quality support to technical transfers, new product introductions, validation activities and quality operations projects including serialization and quality risk management. The ideal candidate will have prior experience leading or participating in project teams, strong regulatory knowledge and knowledge of contract manufacturing operations. The role will involve developing and improving systems. The ideal candidate will have excellent interpersonal, communication and presentation skills. The role will require knowledge of project management methodologies and an ability to prioritize, organize and manage multiple tasks to tight deadlines.
Support the coordination of 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.
Provide quality/compliance support 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.
Coordinate quality metrics programs in relation to Third Party performance.
Provide support to Quality Operations Management Team in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties.
Assist in the preparation of Quality Agreements with the Third Party Manufacturers and Alliance Partners.
Review 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.
Provide support to specified quality and technical projects as they arise
Minimum 5 years experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency.
A BSc in a scientific discipline such as Chemistry or Microbiology.
Project management experience is desired.
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.