Quality Assurance Specialist
Vor 7 Tagen
Company Overview:
Gloor&lang AG is a leading biopharmaceutical company dedicated to providing innovative treatments for rare diseases. Our commitment to quality and excellence has earned us a reputation as a trusted partner in the industry.
Job Description:
We are seeking an experienced Product Quality Lead to join our Global Quality team. As a key member of our team, you will be responsible for leading a quality improvement project focused on streamlining 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 Responsibilities:
- 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.
Requirements:
- Educational Background: University degree (minimum 4 years) 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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