Global Product Quality Manager

North Dublin
20 February 2018
20 March 2018
Position / level
Manager, Professional
Contract Type
Full Time

Key Responsibilities:

  • Maintains the primary quality lead with management oversight for project quality activities.
  • Leads the development of global QA strategy to support pharmaceuticals, biologics, and devices produced on site and through TPM facilities.
  • Makes key decisions on product quality and compliance and regulatory conformance issues.
  • Establishes and maintains relationships with TPMs, on site plants, affiliates and other functional groups to maintain roles and responsibilities.
  • Communicates and negotiates with external companies’ quality organization to maintain a consistent level of quality.
  • Liaise with Quality Assurance audit team to develop audit and inspection readiness plans.
  • Manages Quality Assurance elements needed to facilitate new product launches. Drives implementation of the Product Transfer Process from R&D to sites.
  • Develops product quality transfer process monitoring metrics
  • Completes management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues.
  • Work with Affiliates and Regulatory to prepare submissions. 

Education & Experience:

  • Bachelor’s Degree in relevant Life Science or other technical discipline or equivalent job experience required.
  • Minimum of 8 years of total combined experience. At least 5 years in Quality Assurance Operations Management; 3 years in Operations, Research and Development, Regulatory or Consulting.  Direct Plant experience in a Pharmaceutical setting is a requirement.
  • Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, devices, OSD, capsules, XL, and/or APIs).
  • Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background is required.
  • Experience with FDA and other regulatory agency interactions and inspections.
  • Familiarity with the requirements for third party external manufacturing.
  • Ability to travel (25%).

If you would like to apply for this exciting Senior Global role in one of the world's largest pharmaceutical/biopharma companies and you meet the criteria above contact Clara Henry on 01 4744676 for a confidential discussion or click APPLY.