Clinical Development Quality Manager
- Permanent
- Quality Assurance
This vacancy has now expired. Please see similar roles below...
Hobson Prior are currently working with a swiss based biopharmaceutical company who are seeking a Clinical Development Quality Manager to join them on a permanent basis in Lausanne. This role will ensure that the clinical studies sponsored by the organisation and pharmacovigilance activities related to Investigational Medicinal Products are conducted in compliance with international guidelines (Good Clinical Practices) and applicable regulations.
Job Responsibilities:
- You will represent as the GCP expert for the Clinical Development department of DPI and actively support the development of appropriate clinical development processes, systems and tools to ensure compliance with GCP.
- Promote the Quality Culture and actively collaborate to the GxP training activities.
- Develop and maintain the Clinical Development Quality Systems and related SOPs in compliance with the laws and regulations governing GCP and the applicable guidelines for the pre-marketing pharmacovigilance activities.
- Develop and maintain Quality Agreements with Contract Research Organizations/Vendors and ensure proper review of Vendors agreements to ensure compliance with Good Clinical Practices.
- Ensure the appropriate training of concerned collaborators involved in GCP activities through the oversight of the DPI training management system (Ennov Training) and the setting-up/delivery of specific training sessions on clinical quality subjects, new/revised processes, regulations/guidelines, company improvement initiatives, as needed.
- Perform or coordinate the conduct of external audits of investigational sites and Contract Research Organizations/Vendors to verify their compliance with GCP and/or GVP, review and follow-up or related CAPAs.
- Setting up the internal clinical development system audits plan and perform or coordinate the relevant internal audits and for cause audits, support the establishment of the CAPAs and ensure regular follow-up of CAPAs with the internal auditees.
- In partnership with concerned functions, coordinate the preparation and assist in hosting external GCP audits of DPI (e.g. DPI's partners) as well as of regulatory inspections of DPI, investigational sites, vendors and partners.
- Follow-up until resolution on all Corrective and Preventive action plans associated with clinical and pharmacovigilance activities resulting from any source.
- Tracking and monitoring the Quality Events (Deviations, Change Controls, CAPAs and other events) and communicating to Management the monitoring trends and related improvements in line with the applicable regulations/guidelines.
Key Skills:
- Rigor, flexibility, adaptability and organization.
- Pragmatism focused on efficiency and continuous improvement.
- Fluent in English, French an asset.
Requirements:
- University degree (master's degree or Ph.D. in a biomedical subject, nursing degree, etc.).
- 10 years of experience in Quality Management including involvement in managing clinical Quality Management system and compliance audits & inspections, CAPAs.
- Experience in managing and conducting GCP audits (CROs, TMF, Investigational Sites and CSR).
- Excellent knowledge of GCP.
- Experience in setting and updating clinical quality SOP's.
- Experience in the mechanism of multiple QA vendors oversight.
- Knowledge of computerized systems validation.
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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