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Quality Manager

  1. NI & Ireland
  1. Contract
  1. Compliance / Quality Assurance
Date Posted08 Jan 2021
Quality Operations Manager, Drug Product, EMEA and Asia Pacific

Ireland is a hive of activity for the Life Sciences Industry at present with no shortage of major expansion/ new build facilities. We have an exciting opportunity for a Quality Operations Manager to join a project for a global pharmaceutical organisation with great longevity of employment possibility.

Located within a commutable distance of one of Ireland’s international airports, this position would suit both local candidates or those wishing to commute from outside of Ireland.

The Role

Our client is looking to recruit a Quality Operations Manager, Drug Product,

EMEA and Asia Pacific on a 12 Month Contract to provide quality and compliance oversight support to the Quality Operations management team within External Manufacturing.

Key Duties and Responsibilities:
  • Coordination of quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships.
  • Actively support the Fact Finding (FF) and Product Review Committee (PRC) processes for major investigations involving Third Party products.
  • Provide quality/compliance management 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 management to Global 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.
  • Manage Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties.
  • Manage the preparation of Quality Agreements with the Third Party Manufacturers and Alliance Partners.
  • Review the Annual Product Reviews submitted by the Third Party Manufacturers.
  • Manage the Global external auditing program by participation in audits of Third Parties as requested.
  • Manage specified quality and technical projects as they arise.

Qualifications, Knowledge and Skills Required:
  • In depth knowledge of cGMP regulations pertinent to the USA, EU and other international markets
  • Management/ Lad experience within Quality
  • Ability to develop cross-functional and external working relationships
  • Strong communication and presentation skills across all levels both internal and external to The Client.
  • Proven analytical and problem solving skills.
  • A BSc in a scientific discipline such as Chemistry or Microbiology
  • Minimum 8 years’ experience in the pharmaceutical industry, preferably in Quality Lead or Management position,
  • Manufacturing Technology, Regulatory or a position within a Health Authority Agency
  • Experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables first-hand 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

If this role is of interest to you then please apply! 

The candidate must have the rights to work in the location stated in the job advert.

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