Providing Flexible Resourcing Solutions
Founded in 1997 and headquartered in Basel, Switzerland, CTC is a specialist life-sciences recruitment organisation. We place specialist talent into contract and permanent positions in the pharmaceutical, biotech, medical devices and CRO industries.
An in-depth experience in life-sciences recruitment combined with an established and extensive local network means that CTC offers clients and candidates the “Gold standard” in recruitment services. With an expertise honed over many years at the cutting-edge of the life-sciences industry, we help companies find people and we help people find companies.
GCP Quality Manager
Our client, a dynamic bio-pharmaceutical company headquartered in Switzerland and covering multiple therapeutic areas, is looking for a GCP Quality Manager for a permanent role based in the French Speaking area of Switzerland.
As a GCP Quality Manager you will ensure that the clinical studies sponsored by the company and pharmacovigilance activities related to Investigational Medicinal Products (IMPs) are conducted in compliance with international guidelines (Good Clinical Practices (GCP) and applicable regulations, through the maintenance and constant improvement of adequate quality systems.
Your main responsibilities:
- Act as GCP expert for the Clinical Development department of the company;
- Develop and maintain the Clinical Development Quality Systems and related SOPs in compliance with the laws and regulations governing GCP;
- Develop and maintain Quality Agreements with Contract Research Organizations/Vendors and ensure proper review of Vendors agreements to ensure compliance with Good Clinical Practices (GCP);
- Ensure the appropriate training of concerned collaborators involved in GCP activities through the oversight of the training management system and the setting-up/delivery of specific training sessions;
- Perform or coordinate the conduct of external audits of investigational sites and Contract Research Organizations/Vendors to verify their compliance with GCP and/or GVP, review and follow-up or related CAPAs.
- Communicate to Management the CAPAs monitoring and related improvements;
- Setting up the internal clinical development system audits plan and perform or coordinate the relevant internal audits and for cause audits,
- In collaboration with concerned functions, coordinate the preparation and assist in hosting external GCP audits of the company (e.g. company’s partners) as well as of regulatory inspections, investigational sites, vendors and partners;
- Follow-up until resolution on all Corrective and Preventive action plans associated with clinical and pharmacovigilance activities resulting from any source (e.g. deviations, audits and inspections, improvement suggestions).
- University degree (for instance Master’s degree or Ph.D. in a biomedical subject, nursing degree, etc.);
- 10 years of experience in Quality Management including involvement in managing clinical Quality Management system and compliance audits & inspections, CAPAs;
- Experience in managing and conducting GCP audits (CROs, TMF, Investigational Sites and CSR);
- Experience with FDA/EMA inspections;
- Experience in setting and updating clinical quality SOP’s;
- Experience in the mechanism of multiple QA vendors oversight;
- Knowledge of computerized systems validation;
- Rigor, flexibility, adaptability and organization;
- Pragmatism focused on efficiency and continuous improvement;
- Capacity to think strategically and to keep an overall view while bringing efficiency to daily detailed activities;
- Fluent in English, French an asset;
- Relevant working/residency permit or Swiss/EU-Citizenship required.