Global Quality Assurance Director
hace 2 días
Galderma, a leading dermatology company with a rich legacy and commitment to innovation, is seeking an experienced professional to join its team as the Global Quality Assurance Director. Located in Barcelona, this role offers a unique opportunity to make a direct impact on the company's growth and success.
About UsWe are a pure-play dermatology category leader, present in approximately 90 countries. Our innovative science-based portfolio of premium flagship brands and services spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, 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.
We understand that the skin we're in shapes our lives, and we are advancing dermatology for every skin story. We look for people who focus on getting results, embrace learning, and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day.
Job DescriptionThis role will be responsible for establishing, maintaining, and developing Galderma's Global Quality Management System, ensuring compliance with relevant government regulations such as cGMP, GDP, ISO, and Medical Devices regulations. The successful candidate will manage global quality system topics, create and revise global documents, establish and maintain training plans, and develop and maintain quality KPIs and reporting.
The incumbent will work closely with stakeholders and managers to ensure the qualification status of tools such as electronic Quality Management Systems (eQMS) and electronic Document Management Systems (eDMS). They will also participate in Global Quality Reviews and prepare and manage an annual audit program to ensure vendors' oversight in areas of cGMP, GDP, ISO, and Medical Devices regulations.
Requirements- A background in Medical Device, pharmaceutical, or biopharmaceutical industry.
- Demonstrated knowledge and execution of Quality System Management.
- Knowledge of different regulations: Medical Device applicable regulation (NF EN ISO 13485; CMDCAS; directive 93/42/EC; 21 CFR 820, ...).
- GMP (FDA, EU, ICH, PICs regulations, cGMPs related to all major territories), GDP regulatory requirements.
- Solid background in MS-Office suite and other IS tools.
You will receive a competitive compensation package with a salary range of €80,000 - €110,000 per annum, depending on experience, plus a bonus structure and extended benefit package. You will also have the opportunity to work in a hybrid work culture and participate in feedback loops to establish a personalized career path. Join us in creating a workplace where everyone feels valued and empowered to grow and take on accountability.
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