Pharmaceutical Quality Manager
vor 1 Woche
Sobi, Inc is seeking a highly skilled Pharmaceutical Quality Manager to join our team. The successful candidate will be responsible for ensuring compliance with current GMP & GDP regulations, quality technical agreements, and Sobi procedures and policies.
Key ResponsibilitiesThe Pharmaceutical Quality Manager will be responsible for:
- Serve as the primary contact for all quality-related activities with external suppliers.
- Ensure compliance with GMP & GDP regulations and Sobi's Quality System.
- Oversee product release, supplier qualifications, and quality technical agreements.
- Implement and maintain quality risk assessments and KPIs.
- Manage quality issues, audits, and change requests.
Key Qualifications:
- In-depth understanding of GMP requirements of FDA, EMEA, or other health authorities.
- Strong understanding of risk assessment and risk management fundamentals/tools.
- Excellent verbal and written communication skills.
- Fluently spoken and written English.
- Degree of at least 160 university credits in the field of pharmacy, medicine, veterinary medicine, chemistry, technology, or natural science.
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