
GMP Quality Manager
vor 1 Tag
Global Pharmaceutical Quality Manager:
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 Key Responsibilities:
- Develop and implement quality improvement initiatives to drive process efficiency and ensure successful implementation.
- Manage product quality oversight for 1-3 medicinal products, ensuring compliance throughout their lifecycle.
- Collaborate with cross-functional teams involved in product lifecycle management to ensure seamless execution.
- Provide assessment, guidance, and regulatory oversight on all product quality aspects.
- Ensure audit and inspection readiness in collaboration with internal teams.
Required 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).
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