Job Details

Job Summary:

Based in Switzerland, our client is one of the top leaders in pharmaceutical development. This role sits in a new team of experts and aims at keeping up and developing quality within the organization. Please contact Marc Van de Voorde on +41 (0)41 710 51 00, alternatively send your CV in full to CV@advregulatory.com.

Requirements:

*** OPTION CLINICAL QUALITY ASSURANCE *** SWITZERLAND

Based in Switzerland, our client is one of the top leaders in pharmaceutical development. This role sits in a new team of experts and aims at keeping up and developing quality within the organization.

This position will be the lead and subject matter expert for GCP, playing a key role in ensuring GCP compliance at investigator sites and selected vendors, as well as reviewing clinical study reports, documents, and regulatory submissions for clarity and accuracy.

Your will develop and lead the Clinical Quality Assurance group and ensure that Standard Operating Procedures as well as current Work Practices are in accordance with GCP and GLP guidelines and meet all required regulatory requirements.

You will work in close collaboration with Regulatory Affairs, Clinical, Clinical Operations as well as with other stakeholders to ensure compliance with applicable GCPs, GLPs, SOPs, and maintain inspection readiness”. You will also recommend and enforce corrective actions for all identified deviations of above. Furthermore, you coordinate all training activities in respect to GCP, GLP, QA and GpVP.

You will have eight or more years of experience in the pharmaceutical or biotechnology industry with a minimum of five years of relevant experience in Clinical Quality Assurance. Extensive auditing experience across full range of clinical audit types such as CROs, Investigator sites, protocols, clinical study reports, systems and submissions is necessary. In this team leader role you will have exceptional leadership and people management skills as well as having attention to detail and accuracy.

Advanced is retained on this position and thanks you for your application.

Please contact Marc Van de Voorde on +41 (0)41 710 51 00, alternatively send your CV in full to CV@advregulatory.com.

Keywords Key words: QA, QC, quality, GCP, quality assurance, clinical, SOP, GLP, leadership, CSV, gpvp, GMP, Switzerland, Netherlands, Belgium, Luxemburg, Amsterdam, Brussels, audit, CRO