Senior QA Manager - GCP (Home based - EU)
A growing European Headquartered Global CRO is looking for an experienced Senior QA Manager - GCP. This is a brilliant opportunity to join one of the largest independent CROs who provide flexible solutions whilst providing depth and breadth in multiple therapeutic and scientific areas.
- Capable of independently conducting work related to the development, improvement and daily management the company's QMS as well as conducting all types of GxP audits including system audits according to the company's policies, SOPs and regulatory requirements.
- Broad experience in clinical research and quality management and is able to provide support and advice throughout this area.
- Prepare, conduct and follow up on all types of internal and external GxP audits including system/process audits, vendor audits, investigator site audits, and pharmacovigilance audits, TMF audits, document audits (e.g. CSRs), database audits, CSV / computerised system audits.
- Provide quality management advice and support to internal and external customers.
- Support and guide operational staff in preparing for customer audits and regulatory inspections.
- Support, guide and facilitate customer audits including system/process/qualification audits and regulatory inspections.
- Peer review of audit reports.
- Act as Quality Lead auditor when applicable.
- Train other Quality & Compliance personnel as required.
- Participate in internal meetings as required and liaise with other departments as necessary.
- Actively and independently contribute to the development and improvement of the company's Quality Management System (QMS).
- Actively contribute to continuous improvement of the organisation and processes/procedures development to enhance the work at the company.
- Develop new and review existing Quality & Compliance SOPs as required.
- Maintain required knowledge of applicable regulations and company GxP standards and
- Assist in writing SOPs for other departments.
- Assist in providing input into proposals, which include Quality & Compliance.
- Assist with business development of external Quality & Compliance services.
- Accompany Commercial Operations colleagues on customer visits and participate in
presentations when required.
Skills and Requirements:
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Steve Fuller at +44 203 854 2630 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.