QA Senior Specialist, Actives and Intermediates

Qlty Assurance Methods

icon-location-marker Dublin - IE
Posted 146 days ago Full_time R1518831

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 QA Senior Specialist, Actives & Intermediates based in Ireland. The role will be responsible for the quality oversight of our contract manufacturers (CMOs), supplying various APIs, chemical intermediates and starting materials to the Global market. The QA Senior Specialist, Actives & Intermediates will provide Quality Operational support and will report directly to the Quality Operations Manager .

Key responsibilities will include, but not limited to:

  • Proactively manage contract manufacturer relationships from a quality and compliance perspective. Build strong effective working relationships with CMO’s
  • Develop and manage the quality events, change control and market complaints programs in respect of contract manufacturers. Ensure an effective deviation management system is in place to deal with vendor non-conformances from third party suppliers. Review process validation protocols and reports and also process verification/campaign reports for CMO’s where relevant.
  • Ensure qbD principles are implemented for all new products at CMO’s. Review and approval of process risk assessment, process verification reports for CMO’s for intermediates and API. Support pre-approval inspections
  • Manage all activities associated with vendor approvals
  • Provide Technical Quality/compliance subject matter expertise 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.
  • Manage the quality metrics programs in relation to CMO 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 CMO’s
  • Review and approve the Annual Product Reviews submitted by the CMO’s Support the Global BMS external auditing program by participation in audits of Third Parties as requested.
  • Mange information/provide information for quality council meeting
  • Assess and implement corporate policies and directives
  • Liaise with auditors of external vendors and suppliers. Review vendor audits to identify trends

Qualifications and Experience required:

  • The successful candidate will have 3 years of API (Active Pharmaceutical Ingredients) experience  and 3 years of experience at Quality operations site  to efficiently support the selection of new contract manufacturing partners and suppliers.
  • In addition the candidate must be competent to work across cultures and geographies in an integrative manner.
  • A BSc Chemistry or other relevant scientific BSc, in addition to a minimum of five years of experience in a GMP environment, having spent a minimum of five years in a QA position. 
  • Excellent communication skills and relationship building expertise with both suppliers and business partners. 
  • Goal-oriented approach to project management coupled with the ability to manage simultaneous projects. 
  • Excellent organisational and administration skills are required in addition to strong interpersonal skills.
  • Thorough knowledge and understanding of Regulatory requirements and filing processes is required.
  • Operational Excellence qualifications are an advantage.
  • Confident management of internal and external stakeholder relationships
  • 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.

  • In the absence of the Associate Director, Quality Operations Global API, the Quality Operations Senior Specialist can act as designee, review and approval of change controls, signatory on  GMP documentation, representation at meeting.

Note: Travel will be required on a routine basis as part of this role (approx. 25%).

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.