- This position is responsible for providing ex-US audit support and GCP oversight of Clinical Development teams to the Head of company QA-GCP.
- This job will include the execution and management of company QA-GCP audits and the provision of GCP guidance and advice across relevant Clinical Development groups.
- Plan, schedule and conduct audits of Clinical Investigator Sites, CROs, and Clinical submission documents.
- Coordinate responses and corrective actions from audit findings.
- Provide GCP advice and support to company Clinical Operations and other relevant functions.
- Stay abreast of EU clinical trial requirements, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the EU and other regions, as appropriate.
- Assist in the review and revision of Clinical Development and QA SOPs.
- Conduct GCP training for company staff.
- Alert QA GCP Management of internal and external GCP compliance and clinical trial issues in a timely manner.
- Become thoroughly familiar with assigned company compounds and protocols.
- Provide support for regulatory authority inspections including conducting pre-inspection audits of sites.
- Assist with the management of QA consultants performing audits on behalf of the company.
- Bachelor’s degree
- 5 – 10 years’ experience in a pharmaceutical or bio-pharmaceutical company in a GCP QA role with a minimum of 5 years’ experience performing GCP audits of CRO’s and investigator sites.
- Ability to travel up to 40%.
- Strong written and oral communication skills.
- Prior inspection experience preferred.