Clinical Quality Assurance Manager

Position reporting to Global Head of R&D Quality Assurance / Innovation Quality

Mission To assure the quality and GCP compliance of Clinical Development activities sponsored by Company as well as related processes and systems

Scope Clinical Development activities conducted in a regulated environment and more specifically GCP regulated activities.

Duties and Responsibilities - Support the development of the R&D Quality Assurance strategy covering sponsored R&D projects and ensure its implementation in the framework of Clinical Development activities,

• - Develop R&D Quality Assurance objectives dedicated to Clinical Development in line with this strategy and budget constraints.
• - In collaboration with the Audit Program Manager, coordinate the development and implementation of the R&DQA/Innovation Quality audit program dedicated to sponsored clinical development projects/studies and qualification of GxP service providers,
• - Conduct internal (documents, processes, systems) and external audits in line with effective audit programs,
• - Assure the compliance of clinical development activities with the company outsourcing governance by evaluating the GCP impact of outsourced activities, defining and conducting appropriate qualification plans of GCP services providers,
• - Act as R&D Quality Assurance/Innovation Quality representative of the clinical study teams providing GCP quality assurance/compliance expertise and assuring a proactive and reactive quality approach in the framework of sponsored clinical development projects/studies,
• - Contribute to the development and optimization of the Quality Management System dedicated to Clinical Development by supporting the regular update/optimization of applicable controlled documents (Policies, Standard Operating Procedures, Work Instructions and Forms),
• - Support regulatory intelligence activities ensuring the compliance of Clinical Development Quality System with effective regulations and guideline,
• - Provide appropriate training ensuring the buy-in by R&D employees of the quality management system and corresponding regulations and guideline,
• - Participate to the quality analyses of first priority projects to identify any compliance trend that would potentially jeopardize the admissibility of their results by Competent Authorities,
• - Assure international inspection readiness of R&D activities and coordinate GCP regulatory inspections conducted by Competent Authorities world-wide,
• - Represent R&D Quality Assurance at dedicated congresses and promote the image of the Company.

Education and Training Master’s degree in pharmacy, life sciences or similar related fields

English fluent written and oral (other spoken languages as a plus)

Confirmed expertise in Good Clinical Practices and associated regulations

Personal Profile in line with Company values

Experience 10 years of experience in R&D activities and Quality Assurance

Robust experience in R&D audits, inspections and development/implementation of Quality Management Systems

Familiar with R&D IT environment, tools (Documentum platform, Trackwise, Trial Interactive….) and validation approach (GAMP, 21CFR part 11…)

Compensation

The anticipated base salary range for this position is $180,000 – $210,000 annually. This range represents a good-faith estimate of what The Company reasonably expects to pay for this position at the time of hire. Actual compensation will be determined based on factors including relevant experience, skills, qualifications, and internal equity.