Director External Site Quality

A global innovator and leading biopharmaceutical company that has been inventing new ground breaking treatments for numerous life threatening diseases for more than a century. Through this organisations prescription medicines, vaccines, biologic therapies, and animal health products, they work with customers and operate in more than 140 countries to deliver innovative health solutions. As a result of expansion, a decision has been made to bolster this organisations third party QA oversight here in Ireland with a number of highly skilled positions on offer, including Director of External Site Quality.

The Position:

The Director of External Site Quality will act as a sole contributor with responsibility that will involve the implementation of Quality Operations policy, and perform all Quality Operations responsibilities supporting externally manufactured products through this organisations external CMO network. This encompasses oversight of manufacturing, testing, packaging, storage, and distribution of sterile pharmaceutical products, API intermediates, API, non-sterile pharmaceutical products, biologics, drug delivery devices and consumer care products. These activities include assuring that products are produced from approved processes in conformance to all applicable regulatory requirements and company policies and may include the release of all manufactured products.

In your capacity as Director of External Site Quality you will also:

  • Act in a leadership role, monitoring and maintaining the businesses external partners compliance with the FDC Act, Current Good Manufacturing Practices Regulations, and other pertinent legal requirements
  • Ensure the quality performance of external partners through direct oversight, support and technical advice, counselling to the CMO’s site senior leadership and providing on-site supervision as appropriate
  • Provide support to build effective quality systems and drive CI activities with external partners.

The Person:

  • BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred
  • Minimum of 10 years’ experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality, Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements
  • Competent in analysing complex product, production and testing issues and have demonstrated scientific problem solving capabilities

To learn more apply on line or call Shane Browne on +353 1 6321865.

Salary: On Application Location: Nationwide