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Senior Quality Assurance Manager
hace 1 mes
We are seeking a highly experienced Senior Quality Assurance Manager to join our team at Galderma Pharma S.A. The successful candidate will be responsible for ensuring the quality and GLP compliance of Pre-Clinical Development activities sponsored by Galderma.
Key Responsibilities:
- Establish the R&D Auditing strategy dedicated to pre-clinical development activities related to Prescription, Aesthetics and Cosmetics Galderma sponsored projects.
- Define, manage, implement and, as necessary, adapt with R&DQA/Innovation Quality partners the audit program.
- Conduct internal and external audits.
- Assure the compliance of pre-clinical development activities with the company outsourcing governance.
- Contribute to the development and optimization of the Quality Management System dedicated to Pre-Clinical Development.
- Support regulatory intelligence activities.
- Provide appropriate training ensuring the buy-in by R&D employees of the quality management system and corresponding regulations and guidelines.
- Participate in the quality analyses of Galderma first-priority projects to identify any compliance trend that would potentially jeopardize the admissibility of their results by Competent Authorities.
- Assure international inspection readiness of Galderma R&D activities and coordinate GLP regulatory inspections conducted by Competent Authorities worldwide.
Requirements:
- Effective experience in R&D activities and Quality Assurance.
- Robust experience in R&D audits, inspections and development/implementation of Quality Management Systems.
- Be familiar with R&D IT environment, tools (Documentum platform, Trackwise, Trial Interactive....) and validation approach (GAMP, 21CFR part Confirmed expertise in Good Laboratory Practices and associated regulations.
What We Offer:
- A competitive compensation package with bonus structure and extended benefit package.
- A hybrid work culture.
- Feedback loops, during which a personalized career path will be established.
- A growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability.
