Job Description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Responsabilities:

* 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

Required Competencies:

* 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

Required Qualifications:

* 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
* 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
* 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
* 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

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.