Head of Quality & Compliance
An up-and-coming biotech company near Marseille are hiring a Head of Quality & Compliance at their manufacturing site. The position is responsible for developing and maintaining the Company's Quality System as well as strategic control of the Quality department.
The role will cover the whole value chain of the company's portfolio, from Discovery to Post-Marketing programs, as well as managing the auditing programme.
Responsibilities of the Head of Quality & Compliance include:
- Oversees the implementation and management of the company's Quality System
- Assure proper documentation; change controls, deviations, CAPAs, SOPs, validation protocols, product specifications, training documentation, etc
- Define appropriate KPIs
- Establish an appropriate audit program (internal, external)
- Lead internal and external audits
- Manages human resources in the Quality department (recruitment, evaluation, training, development)
Requirements:
- 7+ years' experience in Pharmaceuticals or Biotech with a focus on Quality Management
- Extensive GxP quality experience in clinics and post-marketing
- Knowledge of cGMP, GLP, ICH, and EP, USP, BP regulations or guidelines
- Advanced knowledge and understanding of GxP regulatory requirements and implementation (FDA, EU, ICH & country specific regulations and other relevant guidance governing GxP activities)
- Excellent communication and organisational skills
- Fluent in English and French
Renumeration
- €90,000 - 120,000 gross annual base salary
- 10 - 15% incentive bonus
- Secondary benefits; Pension, etc.
