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 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.