Quality Lead in Pharmaceutical Industry
Vor 7 Tagen
We're seeking an experienced Product Quality Lead to join our team at Gloor&lang AG As a key member of our team, you'll play a crucial role in driving quality excellence and ensuring compliance with GMP regulations.
As a Product Quality Lead, you'll be responsible for:
Quality Improvement Project (50%)
- Developing and implementing a cross-functional quality improvement initiative to enhance change control handling in regulatory dossiers and release processes.
- Ensuring compliance with GMP regulations and pharmaceutical quality standards.
- Providing project management support, including planning, scheduling, and coordination of activities.
- Collaborating with stakeholders to drive process efficiency and ensure successful implementation.
Product Quality Lead Responsibilities (50%)
- Acting as key Quality Assurance contact for medicinal products, ensuring compliance throughout their lifecycle.
- Providing assessment, guidance, and regulatory oversight on all product quality aspects.
- Supporting cross-functional teams involved in product lifecycle management.
- Ensuring audit and inspection readiness in collaboration with internal teams.
Your Profile
- Educational Background : University degree in Pharmacology, Biochemistry, Chemistry, Chemical Engineering, or equivalent.
- Industry Expertise : At least 5 years of Quality Assurance experience in commercial pharmaceuticals under GMP.
- Regulatory & Compliance Knowledge : Strong understanding of EU / FDA GMP requirements, regulatory dossiers, and release processes.
- Project Management : Proven track record in pharmaceutical project management, ideally with complex supply chains & CMO / CLO management.
- Communication & Leadership : Excellent stakeholder management skills, with the ability to work collaboratively in a global team environment.
- Language Skills : Fluent in English (spoken & written).
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