Quality Assurance Manager

2 weeks ago

Work From Home, United Kingdom MAC Clinical Research Full time
Job Description

**Job Title:** Quality Assurance Manager

**Job Summary:**

We are seeking a highly skilled Quality Assurance Manager to join our team at MAC Clinical Research. As a Quality Assurance Manager, you will be responsible for managing system, study, and vendor audits, as well as other quality assurance activities to meet customer expectations.

Key Responsibilities:

  • Manage system, study, and vendor audits to ensure compliance with regulatory requirements and customer expectations.
  • Design, implement, report, and follow-up on quality assurance audits and activities within the CRO business.
  • Perform and train others in quality assurance audits and activities within the CRO business.
  • Manage quality issues arising and implement corrective actions.
  • Manage audit and other quality assurance documentation and follow-up on findings.
  • Assist the QA team in study/system/vendor audits and other quality assurance responsibilities as required.
  • Comply with MAC health and safety policy and MAC policy on equality and diversity.
  • Maintain professional qualifications and engage in continuous personal development.
  • Work according to MAC SOPs, guidelines, and policies, and current data protection standards.

Requirements:

  • A minimum of 5 years' experience of GCP-focused audits and other quality assurance activities within a CRO.
  • Experience and regulatory expertise of industry quality systems/standards, including awareness and understanding of the MHRA Phase 1 accreditation scheme.
  • Logical approach to problem analysis and solutions.
  • Excellent initiative to work alone and with a team.
  • Good skills with MS Office.
  • Design and implementation of quality assurance SOPs, in conjunction with the QA team.

What We Offer:

  • Competitive salary in keeping with pharmaceutical industry standards.
  • Health Insurance.
  • Free onsite parking.
  • 25 days annual leave (increasing in increments to 30 days after 6 years' service).
  • Your birthday off work.

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