Regulatory Compliance Lead MS&T
4 days ago
Galderma: A Pioneer in Dermatology
At Galderma, we are committed to advancing dermatology for every skin story. Our cutting-edge portfolio of premium flagship brands and services spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology.
Our Mission
We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
Job Description
The RoleWe are recruiting two managerial positions within Manufacture, Science and Technology (MS&T) department. One Manager will be responsible for Device Injectable and one for Assembly & Packaging. Each manager will get the opportunity to build up a team of manufacturing scientists responsible for new product implementation (NPI) into the new manufacturing facility and for supporting the commercial manufacturing.
Your Key Responsibilities
- Implementing plans and programs, supporting policies and practices enabling new product manufacturing, end-to-end.
- Enabling smooth transition of products from R&D into full production readiness, with team members representing MS&T in Technology Transfer projects and taking full process ownership.
- Ensuring process efficiency, cycle time, reliability, and serviceability.
- Supplying technical manufacturing process expertise for appointed areas supporting daily operations, projects, regulatory applications, and audit presentations.
- Process validation (PV), process trending programs, and continuous process verification (CPV) where applicable.
- Ownership for medical device design control documentation following product design transfer.
About You
We believe you have solid experience from relevant work in a regulated industry, preferably from the biopharmaceutical or medical device industry, with experience in sterilization. We also hope that you have experience from implementing manufacturing and leading a team. You thrive in a dynamic work environment with extensive cross-functional contact both internally and externally.
Skills & Qualifications
- BSc or MSc degree in a relevant scientific or engineering field, such as Chemistry, Biochemistry, Chemical Engineering, or solid experience of working in a regulated industrial environment.
- Approximately 8 years of experience in a biopharmaceutical and/or medical device environment.
- Previous team management experience.
- Hands-on experience with manufacturing processes, control strategies, and product interactions.
- Experience in processes regarding either Sterilization, Injectables, or Assembly and Packaging.
- Fluent in English.
- Swedish is highly meritorious.
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