Join a leading Global Life Science CDMO as a Head of Quality Assurance & Regulatory Affairs.
This position would have multi-site responsibility across 3 manufacturing sites in Northern France and Belgium.
The Head of QA and Regulatory Affairs provide strategic direction and leadership regarding all aspects of Quality and Regulatory. Ensure the Company’s quality system is in compliance with all relevant regulations and standards set forth by regulatory, quality and/or accrediting agencies. The Director of QA/RA is also responsible for the development of regulatory submissions (whether domestic and international), as well as dealing with any compliance-related matter.
- Manage regulatory activities and set regulatory strategy and policy for all the companies in the scope.
- Provide technical leadership and vision through the interpretation of new and emerging international regulatory trends pertinent to local business needs and develop and implement strategies and projects to optimize regulatory performance.
- Provide technical leadership and vision for the upgrade of our regulatory dossiers for our generic APIs and for the activities to be performed for the development of new generic APIs.
- Interact with Regulatory Agencies to ensure that quality systems are adequate, and facilities are compliant.
- Develop and maintain Regulatory policies and procedures (Standard Operating Procedures, Specific Procedures, training manuals). Lead and ensure timely preparation of organized and scientifically valid product submissions.
- Coordinate and maintain an accurate and useful database of relevant Regulatory information. Translate and process regulatory information for use as needed to perform the function.
- Review system upgrades to ensure document and data integrity is maintained. Work closely with Information Technology to ensure any system verification is properly performed and documented.
- Manage the Quality Assurance group in the development/revision and implementation of Standard Operating Procedures (SOPs) as required.
- Ensure compliance (GMP, …) with appropriate SOP’s according to Health Authorities and ICH guidelines.
- Oversee the development and maintenance of Quality Systems both in-house and oversight at contract manufacturers and raw materials suppliers.
- In link with local QA managers on site, manage audits and support regulatory inspections; Including planning, scheduling, and supporting audits to assure adherence to company quality policies and applicable regulatory requirements.
- Manage the defined Quality improvement plan and facilitate teams to accomplish the deliverables, milestones, and objectives in order to meet the plan
- Manage, coach, and develop the Team in QA and Reg affairs department, to increase the skills of people, the efficiency on the different projects and their abilities to deal with complex projects.
- Identify resource and skill gaps and recruit staff as required and effectively outsource projects as needed