I am partnered with a leading global manufacturer searching for a Director of QA to shape and execute the site's Quality policy, lead a talented team, and push the boundaries of innovation. You’ll have the opportunity to implement strategic improvements that will transform operations and elevate quality standards, all while working with cutting-edge technologies in validation, qualification, and metrology. This position not only offers the chance to make a significant impact but also to collaborate with global stakeholders and contribute to an environment that thrives on continuous advancement.
Primary Objectives:
Develop and implement the Quality policy for the site, ensuring alignment with regulatory standards and company directives.
Oversee pharmaceutical responsibilities for the site, including roles as Qualified Person (QP) and Responsible Pharmacist (RP), ensuring full compliance with applicable regulations.
Key Responsibilities
- Lead the Quality Control Laboratory and manage all related activities.
- Oversee Operational and System Quality Assurance, including Supplier Quality.
- Manage Validation, Qualification, and Metrology functions.
- Define and enforce the site’s Quality Policy in alignment with Site General Management and in adherence to Good Manufacturing Practices (GMP), ISO 13485, ISO 22716, and relevant directives.
- Manage human and financial resources within the Quality Assurance department and the Quality Control Laboratory.
- Develop and validate Quality specifications for clients.
- Ensure compliance with regulatory authorizations and manage product registration dossiers.
- Drive strategic improvements across all site functions: Quality, Environment, Hygiene and Safety, Human Resources, Production, Technical, Budget, and Investment.
- Monitor and address dysfunctions, anomalies, deviations, and complaints.
- Participate in internal and external audits.
- Represent the Quality function to regulatory authorities and notified bodies.
- Analyze Quality risks, set action priorities, and achieve Quality objectives.
- Define and implement Quality objectives and participate in Quality Management Reviews.
- Allocate resources according to the Quality policy and define, validate, and delegate Quality roles and responsibilities.
Requirements
- Must be a registered pharmacist
- Minimum of 10 years of relevant experience required.
- Strong managerial experience
- Fluent in French.
- Must have a background in Sterile Manufacturing