Clinical Quality Assurance Manager - 12 month contract - Allschwil based

RBW Consulting

Schweiz
Freiberuflich
Vollzeit

15 Tage her

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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