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 bachelors 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.