Quality Operations Senior Specialist

Qlty Assurance Methods

icon-location-marker Dublin - IE
Posted 34 days ago Full_time R1517935

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.


Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

BMS 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 to recruit a permanent Quality Operations Senior Specialist 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.

Qualifications, Knowledge and Skills Required:

  • 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
  • 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.

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.
  • You’ll 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.

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 the resources to pursue their goals, both at work and in their personal lives.