You will be reporting to the President of the company, looking after all the Quality Assurance and Regulatory activity across the sites in France, United States and Canada. Your responsibilities include:
Quality Assurance Responsibilities -
* Coordinate, distribute, and keep an eye on the quality system's design, development, and management
* Control the individuals in charge of quality assurance throughout the various businesses.
* To oversee the organization's quality management systems intended to make sure that my client's operations adhere to regulatory standards
* To standardise the procedures between the sites as much as feasible
* To organize training on procedures and regulations
* To guarantee that all operations are carried out in accordance with the guidelines of good laboratory, good manufacturing, and good clinical practises.
Auditing Responsibilities -
* Carry out internal audits
* Carry out external audits of the service providers
* Carry out any audits of new entries
* Organize audits and accompany the promoters' external auditors - Coordinate responses to promoters' external audit reports
* Ensure the follow-up of the implementation of the corrective actions decided following the audits.
Regulatory Responsibilities -
* Ensure global regulatory monitoring
* Assist operational staff in the implementation of new regulatory processes in different parts of the world
* Be the reference on questions concerning regulations
* To ensure the protection of personal data (RGPD) as Data Protection Officer (DPO).
* Holder of a degree in Pharmacy.
* You have more than 10 years' experience in the pharmaceutical industry/clinical research sector.
* You have a strong understanding of Good Clinical Practices and Good Laboratory Practices.
* You have already been in contact with the FDA and ANSM.
* Your natural leadership and your analytical and synthesis skills will enable you to take up this new challenge.
* You are a fluent English and French speaker.
My client has been a trusted service provider for the pharmaceutical company for over 30 years. If you are looking to be a part of a global and rapidly growing team then feel free to get into contact with me via firstname.lastname@example.org