Associate Director of Quality Assurance

3 weeks ago

London, Greater London, United Kingdom MSD Full time

Job Title: Associate Audit Director

Job Summary:

We are seeking an experienced Associate Audit Director to join our Quality Assurance team at MSD. As a key member of our team, you will be responsible for performing comprehensive and detailed GMP compliance audits of human health sites, animal health sites, contractors, business partners, and suppliers.

Key Responsibilities:

  • Perform GMP compliance audits to ensure adherence to regulatory requirements and company policies.
  • Support new business opportunities through due diligence, pre-contract, and Pre-PAI audits.
  • Conduct audits, write-up audit reports, and maintain an understanding of company policies, procedures, and guidelines.
  • Maintain awareness of evolving industry and regulatory trends/regulations.
  • Obtain and maintain auditor qualification through ongoing training and continuing education programs.
  • Coordinate with Site Quality leads on audit refusals and postponements.
  • Lead project initiatives to maintain the effectiveness and efficiency of the audit program.

Requirements:

  • Bachelor's Degree in Science, Chemistry, (Micro-) Biology, Engineering (or equivalent).
  • Extensive experience performing audits and/or quality operations experience.
  • Thorough understanding of Quality Management Systems and processes.
  • Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.
  • Ability to work independently with limited supervision.
  • Review and approve audit reports.
  • Ability to travel approximately 50% of the time.

Preferred Qualifications:

  • Extensive experience auditing biologics and vaccine manufacturing sites.
  • External engagement in regulatory or industry forums.
  • Prior experience at a health authority performing GMP inspections.
  • Knowledge and expertise in application of Quality Risk Management.
  • Experience with development, implementation, and optimization of IT tools.

About MSD:

MSD is a leading healthcare company that invents solutions to meet unmet healthcare needs. We are committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

What We Offer:

At MSD, we offer a dynamic and challenging work environment that allows you to grow and develop your skills. We are committed to our employees' success and offer a range of benefits and opportunities for professional growth.

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