Associate Director, IT Compliance and Systems Management

1 week ago


Dublin, Dublin City, Ireland Merck Gruppe - MSD Sharp & Dohme Full time

Job Description

Join our team in Dunboyne, Ireland, where we are dedicated to advancing Biologics Drug Substance manufacturing in our cutting-edge research facility. We are looking for an Associate Director, IT Compliance and Systems Management, to lead and oversee the compliance of our IT systems.

In this role, you will blend your technical expertise with strong skills in IT compliance and validation. You will champion best practices in computer systems compliance and take ownership of IT systems across multiple laboratories in a fast-paced environment.

Key Responsibilities:

  1. Ensure the validated state of IT manufacturing and laboratory systems is maintained.
  2. Implement a Data Quality Strategy to safeguard GxP data.
  3. Lead a support team in managing new system introductions and upgrades.
  4. Review digital technology for all systems introduced, ensuring strategic alignment.
  5. Engage with lab transformation initiatives for effective technology adoption.
  6. Support internal and regulatory audits as needed.
  7. Manage IT corrective and preventive actions and software development life cycle activities.
  8. Foster a culture of data integrity and quality to protect patients and ensure robust processes.
  9. Conduct internal IT compliance and security reviews.
  10. Ensure compliance with global standards and corporate requirements.
  11. Collaborate with stakeholders to align strategies and service expectations.
  12. Connect with industry groups to promote best practices and standards.

Your Profile:

  1. 10 years of experience in the pharmaceutical or biotechnology sector.
  2. 5 years of experience in quality management or computer systems qualification and validation.
  3. Strong technical knowledge of industry processes.
  4. Proven leadership and team management experience.
  5. Demonstrated project management abilities.
  6. An entrepreneurial spirit, self-starter, and hands-on individual.

Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements: Hybrid

Job Posting End Date: 03/11/2025

Requisition ID: R338108

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