Manager, Quality Operations, Drug Product, EMEA and Asia Pacific

Recruiter
Bristol-Myers Squibb
Employment Type
Permanent
Salary
Not disclosed
Bristol-Myers Squibb logo

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 manufacturing’s global headquarters, the business unit responsible for the management of manufacturing contract operations (CMO’s) 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 /ie

The Role

BMS External Manufacturing is looking to recruit a permanent 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 Duties and Responsibilities:

  • 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: There will be up to 25% percent of travel required as part of this role

Qualifications, Knowledge and Skills Required:

  • 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

What’s important to us

Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:

  • Passion: Our dedication to learning and excellence helps us to deliver exceptional results.
  • Innovation: We pursue disruptive and bold solutions for patients.
  • Urgency: We move together with speed and quality because patients are waiting.
  • Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments.
  • Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
  • Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential.

We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve.

Why you should 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.
  • You’ll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 23.5 days annual leave plus 3 Company days, access to BMS Cruiserath on-site gym, life assurance and gain-sharing bonus.