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Pre-Clinical Quality Assurance Manager
hace 2 meses
We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team at Galderma Services Spain, S.L. as a Pre-Clinical Quality Assurance Manager. This is an exciting opportunity to work in a dynamic and innovative company that is dedicated to advancing dermatology for every skin story.
Key Responsibilities- Establish and implement a robust quality assurance strategy for pre-clinical development activities, ensuring compliance with Good Laboratory Practices (GLP) and associated regulations.
- Conduct internal and external audits to ensure the quality and integrity of pre-clinical development activities.
- Develop and maintain a quality management system that meets the company's outsourcing governance requirements.
- Collaborate with cross-functional teams to ensure the quality and compliance of pre-clinical development activities.
- Provide training and support to ensure the buy-in of quality management system and corresponding regulations by RD employees.
- Participate in quality analyses of Galderma's first-priority projects to identify any compliance trends that may jeopardize the admissibility of results by Competent Authorities.
- Ensure international inspection readiness of Galderma's RD activities and coordinate GLP regulatory inspections conducted by Competent Authorities worldwide.
- Effective experience in RD activities and quality assurance.
- Robust experience in RD audits, inspections, and development/implementation of quality management systems.
- Familiarity with RD IT environment, tools (Documentum platform, Trackwise, Trial Interactive), and validation approach (GAMP, 21CFR part 11).
- Confirmed expertise in Good Laboratory Practices and associated regulations.
- A competitive compensation package with bonus structure and extended benefit package.
- The opportunity to work in a hybrid work culture.
- Participation in feedback loops, where a personalized career path will be established.
- The chance to join a growing company that believes in ownership from day one, where everyone is empowered to grow and take on accountability.
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story.
