GCP QA Manager

We are proud to be partnered with fast growing UK based Biotech company wo are seeking a GCP QA Manager.

Are you a Quality Assurance Specialist with good knowledge of GCP & GMP?

Job Role:

· Supporting the Director of Quality in the management of the QMS

· Ensure the company maintains ‘Inspection Ready Status’ at all times

· Auditing

· Managing the clinical audit programme

· Performing internal, CSP and clinical site audits

· Key Essential Document audits, including Investigator’s Brochure, Clinical Protocols and Clinical Study Reports

· Managing independent auditors.

· Supporting and deputising for the Director of Quality

· Ensuring compliance with GCP and other regulatory requirements.

Qualifications and/or experience required to perform the role

· Four years’ quality assurance experience in a pharmaceutical or Biotechnology organisation

· At least two years’ experience as a Clinical Quality Assurance Associate/Auditor

· Scientific degree

· Good experience of auditing suppliers and clinical investigator sites

· Detailed knowledge of GCP is mandatory

Benefits

-Company and individual bonus

-4 x Life Assurance upon death whilst employed

-Medical Cover with previous medical history disregarded

-Pension – up to 5% matched by company

-Stock options – tbc the amount and pricing

-25 days leave per year plus bank holidays