Senior Quality Manager (GVP)
- Permanent
- Quality Assurance, Auditing
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Hobson Prior are currently working with a medium size leading Clinical Research Organisation who are seeking a Senior Quality Manager to join them on a permanent basis in Stockholm.
Job Responsibilities:
- 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 / computerized system audits.
- Deliver quality management advice and support to internal and external customers.
- Train other Quality & Compliance personnel as required.
- 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.
- Represent as the Quality Lead auditor when applicable.
- Participate in internal meetings as required and liaise with other departments as necessary.
- Actively and independently contribute to the development and improvement of the Quality Management System.
- Actively contribute to continuous improvement of the organisation and processes/procedures development of to enhance the work at the organisation.
- Develop new and review existing Quality & Compliance SOPs as required.
- Maintain required knowledge of applicable regulations and company GxP standards and procedures.
- 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.
Key Skills:
- Good computer skills (Microsoft Word and Excel).
- Ability to work independently and efficiently.
- Good planning, organisation and problem-solving abilities.
- Fluent in English, both written and verbal.
Requirements:
- University/college degree or equivalent industry experience.
- Awareness of global and local industry trends, government policies and regulations in the clinical trials and pharmacovigilance area.
- In depth knowledge of GxP regulations and guidance.
- Previous pharmacovigilance auditing experience is required.
- Thorough knowledge of requirements for PV compliance Knowledge on GxP regulated computerized system validation activities and principles.
- Previous audit management experience.
- Several years' experience in clinical research, (e.g. monitoring, data management, drug safety, training, etc.).
- Five to ten years' experience of auditing in two to three GxP areas.
- International travel to audit sites, worldwide.
- Delegated for other tasks and activities by Quality Operations Director within scope of experience.
Apply now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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