Clinical Development Quality Manager

QualityLausanne, Vaud, SwitzerlandFull time

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Description

Debiopharm Group™ is a Swiss-headquartered global biopharmaceutical group including five companies active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management. Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.

For the Quality Department, we are looking for a

Clinical Development Quality Manager

The incumbent of this role will ensure that the clinical studies sponsored by Debiopharm International S.A. (DPI) 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 DPI and actively support the development of appropriate clinical development processes, systems and tools to ensure compliance with GCP;


• Develop and maintain the Clinical Development Quality Systems and related SOPs in compliance with the laws and regulations governing GCP and the applicable guidelines for the pre-marketing pharmacovigilance (PV) activities;


• Promote the Quality Culture and actively collaborate to the GxP training activities through the Debiopharm Development organization;


• 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 DPI training management system (Ennov Training) and the setting-up/delivery of specific training sessions on clinical quality subjects, new/revised processes, regulations/guidelines, company improvement initiatives, as needed;


• 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, support the establishment of the CAPAs and ensure regular follow-up of CAPAs with the internal auditees. Communicate to Management the CAPAs monitoring and related improvements;


• In collaboration with concerned functions, coordinate the preparation and assist in hosting external GCP audits of DPI (e.g. DPI’s partners) as well as of regulatory inspections of DPI, 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).


• Tracking and monitoring the Quality Events (Deviations, Change Controls, CAPAs and other events) and communicating to Management the monitoring trends and related improvements in line with the applicable regulations/guidelines.

Your profile:

• 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);


• Excellent knowledge of GCP;


• 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.

Debiopharm can offer you:

• An international and highly dynamic environment of a mid-size company.


• The opportunity to join a successful, family-owned, company, at the forefront of the most advanced scientific developments in the industry covering various therapeutic areas and modalities (small molecules, biologics, and radiopharmaceuticals).


• The possibility to work in a company in which people, innovation, and entrepreneurship are the fundamentals of its success.

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