Job Description

We are currently seeking a Quality Assurance Manager to join our team in London, UK. You will manage QA Auditors as well as aspects of projects, investigative site audits and/or business segments as needed. You will develop and oversee employee training. You will also help plan and maintain the annual audit schedule in conjunction with Department Director, including proposing and developing audit plans for new projects. You will work directly with the Clients, as needed.

Responsibilities :

• Independently coordinate the conduct of all types of audits and ensure completion of QA department responsibilities identified by SOPs;
• Oversee and manage auditor capacity planning and audit reporting requirements per procedure;
• Provide line management responsibilities and development for multiple QA Auditors
• Assisting the QA Director with coordinating and conducting internal system audits and external vendor audits for central laboratory and CRO operational functions
• Participate in audits by Sponsors and/or Regulatory Inspectors
• Identify areas of risk and provide input on an effective QA oversight plan to mitigate the identified risk;
• Proactively identify and resolve non-compliance issues within Medpace lines of business;
• Create and revise departmental SOPs and guidelines.

Required Knowledge, Skills, and Abilities

A Bachelor`s degree, preferably in Life Sciences Previous experience in a QA role, within a CRO or pharmaceutical setting is preferred Ability to manage a risk-based approach to the planning and scheduling of all audit types on a company-wide basis; Previous experience overseeing and managing auditor capacity planning and audit reporting Line management experience Demonstrated ability to think strategically; excellent leadership and influencing skills.