RBW Consulting are partnering with a leading Biopharmaceutical organisation in their search for a Senior 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 CRO Clinical Trial Teams during the preparation, execution and closure of clinical trials
- To develop his own area of clinical trial expertise with limited supervision (e.g., self-training, knowledge acquisition by reading / assisting to course identified by himself)
- To ensure CRO Clinical Trial Teams stay compliant with regulatory requirements (e.g., answering questions; participating to meeting to discuss GCP issues)
- To influence and convince CRO Clinical Trial Teams to implement robust clinical trial processes / systems
- To escalate serious / continuing non-compliance GxP issues as appropriate / necessary
- To organize trainings on clinical trial requirements (e.g., ICH-GCP refresher)
- To present ICH-GCP important topics (e.g., CQA audit finding, GCP inspection)
- To contribute in training / mentoring other CQA colleagues Quality Systems
- To manage Quality System documents (e.g., SOP, WIS) creation and management and to ensure it is done in accordance with clinical trial requirements
- To manage / lead process improvements
- To develop / improve CQA tools and processes
- To develop / improve clinical trial electronic systems (e.g., Quality Event Module, clinical trial systems)
- To help with trouble shooting processes and systems GCP Inspection
- To lead / manage the preparation, facilitation and follow up of inspections by international regulatory authorities
- To lead / manage GCP inspection CAPAs elaboration, approval and follow-up CQA Audit for CQA manager expected to be also an Auditor
- To work as per the defined strategy for the global clinical audit program (e.g., site, vendor, process)
- To plan, perform, and report standards and / or complex audits (e.g., site, vendor, process) at the global level
- To lead / 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 6 years of experience within pharmaceutical industry / health authority with at least 3 years’ experience in Quality Assurance (QA) within the ICH-GCP environment
- Knowledge of electronic tools used in clinical trials (e.g., eTMF, ePRO, eSource)
- Reliable, conscientious, agile / flexible, open-minded
- Very good risk analysis and problem-solving skills
- Very good negotiation skills
- Very good writing, verbal and listening skills
- Ability to work as a team player and independently
- Experience working in international cross-cultural relations
- For Senior CQA manager expected to be also an Auditor : ability to travel at least 25% of the time
Please apply here and Harry Henson will be in touch to discuss your application in more detail.
Senior Clinical Quality Assurance Manager - 12 month contract - Allschwil based
RBW Consulting are partnering with a leading Biopharmaceutical organisation in their search for a Senior Clinical Quality Assurance Manager on a 12 month contract in Switzerland. 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 Al...
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