External Site Quality Lead – API

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 Quality Dept at site for an Associate Director – Change Control (QA)

The Position:

  • Governance of the Change Management process on site.
  • Owner of the site Change Review Board meeting, ensuring changes are reviewed and concurred with site Leaders
  • Coaching the team of Change Control Specialists within the department as well as Change Owners from across the site
  • Liaise with Reg Affairs colleagues for changes requiring submission to Regulatory bodies
  • Build relationships with global colleagues to facilitate a streamlined change review and approval process
  • Development of area personnel and provision for succession & delivery of area performance to meet or exceed performance and quality goals
  • Participate and Comply with the MMD Quality Management System (QMS) and Quality Systems Improvement Program (QSIP) requirements, including ownership, as relevant to you.
  • Continuous improvement of systems & procedures on site, to ensure compliance with the most up to date cGMPs
  • Participate in inspections by Divisional Auditing Group and Regulatory Bodies Co-ordination of the area resources to deliver a quality and efficient support service
  • Control of area expenditure within budgetary limits & Contribute to site management operational and strategic initiatives.

The Person:

  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Quality, Science etc.)
  • At least 5 years’ experience in the Pharmaceutical industry or a similar operating environment which includes experience in a management / leadership role in a Quality or Regulatory Affairs function.

To learn more apply online or contact Shane Browne at HRM on +353 1 632 1865.

Salary: On Application Location: Cork