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Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care. Using its products, practitioners can fill all kinds of wrinkles, from the finest to the deepest, to restore youthful volume to the face, and to treat the neck and décolleté, with natural results. The strength of Teoxane is also its human size and independence. Teoxane has total freedom of thought, action and innovation which makes the company unique.
In the frame of the growth of our business, we are looking for an:
CSV Manager
Main activities
- Ensure validated status and regulatory compliance of all computerized systems within scope throughout their lifecycle, maintaining full accountability for conformity.
- Deploy and maintain a standardized CSV methodology, and write, review, and update CSV documentation, procedures, and validation deliverables when necessary.
- Manage staff by proactively balancing workload and resources to achieve operational and project goals.
- Actively manage relationships with internal clients and stakeholders, ensuring clear communication, alignment on priorities, and a strong customer-oriented approach.
- Monitor regulatory changes, optimize CSV processes, and provide expertise for technical solution design and implementation.
- Prepare and present validation files for audits, lead investigations and corrective actions in case of non-conformities and execute operational validation tasks when required.
- Audit suppliers in collaboration with Quality teams and represent company interests in compliance-related disputes.
Your profile
- University degree in Engineering, Computer Science, or related field.
- Minimum 10 years of experience in the pharmaceutical and/or medical device industry, including strong exposure to CSV activities.
- Proven project management and leadership skills, with the ability to train, coach, and develop a team.
- In-depth knowledge of CSV processes, GxP requirements, and current regulatory standards.
- Solid experience in system commissioning, qualification, and lifecycle management.
- Excellent communication, organizational, and problem-solving skills, with strong writing abilities for technical documentation.
- Ability to work proactively, adapt to change, and thrive in a dynamic environment.
- Fluent in French and English (written and spoken).