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Regulatory Compliance Lead
vor 1 Woche
Biopharmaceutical Quality Expert:
We are seeking an experienced Product Quality Lead to join our team at Gloor&lang AG. As a key member of our Global Quality team, you will be responsible for leading a quality improvement project to streamline change control handling in regulatory dossiers and release processes. You will also manage product quality oversight for commercialized pharmaceuticals, ensuring compliance with GMP regulations and pharmaceutical quality standards.
Your Role:
- Lead a cross-functional quality improvement initiative to drive process efficiency and ensure successful implementation.
- Manage product quality oversight for 1-3 medicinal products, ensuring compliance throughout their lifecycle.
- Provide assessment, guidance, and regulatory oversight on all product quality aspects.
- Support cross-functional teams involved in product lifecycle management.
- Ensure audit and inspection readiness in collaboration with internal teams.
Qualifications:
- University degree (minimum 4 years) in Pharmacology, Biochemistry, Chemistry, Chemical Engineering, or equivalent.
- At least 5 years of Quality Assurance experience in commercial pharmaceuticals under GMP.
- Strong understanding of EU/FDA GMP requirements, regulatory dossiers, and release processes.
- Proven track record in pharmaceutical project management, ideally with complex supply chains & CMO/CLO management.
- Excellent stakeholder management skills, with the ability to work collaboratively in a global team environment.
- Fluent in English (spoken & written).
