Regulatory Compliance Specialist
3 hours ago
Sobi is a global biopharmaceutical company transforming the lives of people with rare and debilitating diseases. As a Regulatory Compliance Specialist, you will play a key role in ensuring our external suppliers comply with current GMP & GDP regulations, quality technical agreements, and Sobi procedures.
Job DescriptionWe are seeking an experienced Pharmaceutical Quality Assurance Manager to join our team in Stockholm. The successful candidate will be responsible for managing the quality interface and cross-functional relationships with Sobi stakeholders. They will serve as the primary contact for all quality-related activities with external suppliers and 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.
This role requires a strong understanding of GMP requirements of FDA; EMEA or other Health Authorities. You will have excellent verbal and written communication skills and be fluent in English. Experience within pharmaceutical, biotech product, and QA operation or external quality including supplier quality management (GMP, GDP) is essential.
Serving as a single point of contact with the external supplier, you will have a key role in ensuring compliance and enhancing the product supply of medicines to consumers and supporting the fast growth of Sobi.
Required Skills and QualificationsTo be successful in this position, you should have:
- A degree in pharmacy, medicine, veterinary medicine, chemistry, technology, or natural science.
- More than 10 years of experience within pharmaceutical, biotech product, and QA operation or external quality including supplier quality management (GMP, GDP).
- In-depth understanding of GMP requirements of FDA; EMEA or other Health Authorities.
The successful candidate will also have strong leadership skills with the ability to influence external Suppliers in a cross-functional environment to foster decisions and propose solutions.
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