Regulatory Compliance Expertise Lead

7 days ago


Ballydine Cross Roads, County Tipperary, Ireland MSD Full time

Job Summary: We are seeking an experienced Change Control Topic Lead to join our team, who will be responsible for leading and maintaining the change control business system, providing oversight and guidance on change requests, and mentoring site users of change control systems.

The successful candidate will have a strong understanding of quality policies and procedures, cGMP and manufacturing policies & procedures, and will be able to provide input and guidance on change requests.

Key Responsibilities
  1. Owner and Chair of the Site Change Collaboration Meeting
  2. Attend Supplier Change Evaluation Meetings
  3. Attend Tier 3 Meetings to Discuss Endorsements for All Change Requests with Potential Regulatory Impact
Requirements

To be successful in this role, you will need:

  • A 3rd-level qualification in a Science or Engineering discipline or a related field
  • 5+ years of experience in a related discipline
  • Strong communication skills, both oral and written
  • Project management skills
  • Decision-making and problem-solving skills
  • Leadership principles
  • Quality policies and procedures
  • cGMP and manufacturing policies & procedures
  • Teamwork skills and ability to work across boundaries


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