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 comprehensive and detailed GMP compliance audits of human health sites, animal health sites, contractors, business partners, and suppliers.
  • Support new business opportunities through the performance of due diligence, pre-contract, and Pre-PAI audits.
  • Responsible for accepting audit assignments, performing audit pre-work, conducting audits, and write-up of audit reports within defined timeframes.
  • Maintain an understanding of our 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 to enable the performance of successful audits.
  • Coordinate with Site Quality leads on audit refusals and postponements.
  • Lead project initiatives, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet site, management, and regulatory expectations.

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 to support the manufacturing of drug substances, drug products, and medical devices.
  • Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.
  • Ability to work independently with limited supervision in a virtual-management environment.
  • Review and approve audit reports (as assigned).
  • Must have the 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 pertaining to auditing, above-site function/processes, or technical areas.
  • Experience with development, implementation, and optimization of IT tools to deliver business outcomes.

About MSD:

MSD is a leading healthcare company that is committed to delivering innovative solutions to meet the needs of patients and customers. We are a global organization with a diverse workforce and a strong commitment to quality and compliance.

How to Apply:

If you are a motivated and experienced professional looking for a challenging opportunity, please submit your application today.

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