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.

Bristol Myers Squibb Ireland

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units.

Ireland is home to External manufacturings global headquarters, the business unit responsible for the management of manufacturing contract operations (CMOs) and ensuring reliable supply of product to patients 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 Headquarters based in Dublin 15 and a distribution centre in Shannon, Co Clare.

For more information about Bristol Myers Squibb, visit us at BMS.com/ie

The Role

Bristol-Myers Squibb External Manufacturing is looking to recruit a Manager, Quality Operations , Drug Product, EMEA and Asia Pacific to provide quality and compliance oversight support to the Quality Operations management team within External Manufacturing.

Key responsibilities will include, but not limited to:

* 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.

Please note that there will be 20% travel required as part of this role.

Required Competencies , Qualifications and Desired Experience :

* In depth knowledge of cGMP regulations pertinent to the USA, EU and other international markets
* Ability to develop cross-functional and external working relationships
* Strong communication and presentation skills across all levels both internal and external to BMS.
* Proven analytical and problem solving skills.
* A BSc in a scientific discipline such as Chemistry or Microbiology
* Minimum 5 years experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency
* 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
* Ideally will have experience in interacting with Health Authorities and supporting Health Authority inspections
* Direct experience in interfacing with external manufacturers

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.

Passion: We pursue excellence to help patients prevail.

Innovation: We embrace new ideas.

Accountability: We own our outcomes and the outcomes of others.

Speed: We act with urgency and agility.

Why should you 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.
* Youll 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.

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.