Clinical Quality Manager
An exciting opportunity has arisen for a Clinical Quality Manager in Aubonne. This position has primary responsibility to ensure that the Clinical Trials are compliant with Good Clinical Practice (GCP), relevant regulatory guidelines and the applicable company standards operating procedures.
- Act as GCP expert for the Clinical Development Department and actively support the development of appropriate processes, systems and tools to ensure compliance with the Fresenius-Kabi Quality Management System (QMS).
- Promote the Quality culture within the organisation and actively collaborate to GxP training activities delivered within the FKSBS Clinical Development department.
- Participate in the development and maintenance of Quality Agreements with Contract Research Organisations (CROs) / Vendors as well as proper review of vendor agreements to ensure compliance with GCP.
- Coordinate the conduct of audits (clinical study audits, vendor qualification, internal process audits) within the operating model, in collaboration with the Clinical Operation Department and Fresenius-Kabi Deutschland Clinical QA (FKD CQA) and/or external consultant(s).
- Collaborate with relevant functional leads / project team members both at FKSBS and CROs to coordinate the preparation and hosting of audits and regulatory inspections
- Act as primary CQA point of contact for identified project & process quality issue / event escalation and collaborate with operational representatives on the development of the relevant Corrective and Preventive Action Plan (CAPA).
- Review and follow-up CAPA development, implementation and finalisation.
- Manage audit / inspection reports, CAPA and collection of supportive evidences in FKSBS Clinical QA database.
- Collaborate with the SOP Steering Committee and Clinical Development representatives to review Global / FKSBS SOP applicability, deployment, effectiveness and compliance.
- Collaborate with Clinical Development SOP owner for SOP review, finalisation, deployment and oversight.
- Use outcome of audit / inspection / issue, trend analysis as well as subject matter's expert feedback to identify area of improvements within the FKSBS organisation.
- Maintain a strong collaboration and communication with FKD CQA to streamline expertise and resources in driving compliance with FK QMS.
Skills and Requirements
- A BA/BS, MA/MS or PhD in a scientific discipline or related field
- Minimum 5 years' experience in a Clinical Quality function with increasing levels of responsibility in the pharma industry including involvement in managing clinical QMS, compliance audits, inspections and CAPAs
- Experience in coordinating GCP audits, e.g. CRO, TMF, ISA
- Experience in developing and managing SOPs in Clinical environment
- Experience in managing Clinical QA database
- Strong knowledge of GCP and practical implementation of GCP in clinical trials
- Excellent communication skills in English, both written and oral, knowledge of French and German is an asset
- Demonstrated ability to work effectively in a team-oriented environment
- Demonstrated skills in Leadership, Drive, Intensity, Enthusiasm
- Ability to work as a business partner with Clinical Development functions while successfully driving compliance
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