Clinical Quality Assurance Manager - 12 month contract - Allschwil based

Location Allschwil
Discipline: Clinical Development
Job type: Contract
Salary: £CHF 69.49 - 86.44
Contact name: Harry Henson

Contact email: harry.henson@rbwconsulting.com
Contact phone: +44 (0)1293 364 092
Job ref: 31889
Published: 22 days ago
Duration: 12 months
Expiry date: 29 May 2024 10:59
Startdate: ASAP

​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.