Clinical Quality Assurance Manager - 12 month contract - Allschwil based
RBW Consulting are partnering with a leading Biopharmaceutical organisation in their search for a Clinical Quality Assurance Manager on a 12 month contract in Switzerland.
This company discovers, develops, and commercializes medicines across a wide variety of therapeutic areas.
This role will be a 12 month, 1 FTE contract and it will be hybrid working - a mix of home working and office based in Allschwil.
The hourly rate on offer is in the range CHF 69.49 - 86.44 DOE.
Responsibilities
- To work closely with the CRO Clinical Trial Teams during the preparation, execution and closure of clinical trials
- To support the CRO Clinical Trial Teams in staying compliant with regulatory requirements (e.g., answering questions; participating to meeting to discuss GCP issues)
- To escalate serious / continuing non-compliance GxP issues as appropriate / necessary Provide / Deliver Training / Presentation
- To organize and / or help with trainings on clinical trial requirements (e.g., ICHGCP refresher)
- To organize and / or help presentation on ICH-GCP important topics (e.g., CQA audit finding, GCPinspection)
- To contribute ensuring Quality System documents (e.g., SOP, WIS) creation and management is done in accordance with clinical trial requirements
- To help / contribute to process improvements
- To help / contribute to clinical trial electronic systems (e.g., Quality Event Module, clinical trial systems)
- To help with trouble shooting for processes and systems GCP Inspection
- To participate in management of GCP inspections (e.g., preparation, follow up) by (international) regulatory authorities
- To facilitate the GCP inspection CAPAs elaboration, approval, and follow-up CQA Audit
- To work as per the defined strategy for the global clinical audit program (e.g., site, vendor, process)
- To plan, perform, and report standards ICH-GCP audits (e.g., trial site, vendor, process)
- To manage CAPAs elaboration, follow-up and closure
Experience
- At least a bachelor’s degree or equivalent education / degree in (life) sciences or healthcare
- Experienced in Clinical Research & Development
- Good knowledge of clinical trial regulatory requirements and pharmaceutical industry practices -particularly ICH-GCP
- At least 3 years of experience within pharmaceutical industry / health authority with at least 1 year experience in Quality Assurance (QA) within the ICH-GCP environment
- Interest / knowledge of electronic tools used in clinical trials (e.g., eTMF, ePRO, eSource)
- Reliable, conscientious, agile / flexible, open-minded
- Good risk analysis and problem-solving skills
- Good negotiation skills
- Good writing, verbal and listening skills
- Ability to work as a team player and independently
- Experience and / or willingness to work in international cross-cultural relations
Please apply here and Harry Henson will be in touch to discuss your application in more detail.
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