
Clinical Quality Assurance Manager
3 days ago
Sobi is a global biopharmaceutical company dedicated to transforming the lives of people with rare and debilitating diseases. We are seeking an experienced Clinical Quality Assurance Manager to join our team.
Key Responsibilities:
- Act as the primary quality liaison for external suppliers, organizing inquiries, investigations, and audit follow-ups.
- Maintain oversight of quality topics for Sobi IMPs across markets.
- Continuously improve work processes related to quality and compliance of IMPs.
- Oversee batch record reviews and release for IMPs across US, EU, and RoW clinical trials.
- Monitor and manage key performance indicators (KPIs) related to IMP supplier quality.
- Ensure compliance with Quality Agreements and support revisions in collaboration with internal teams.
- Work cross-functionally with R&D, GCP/GVP QA, QA Supplier Managers and Product Quality Leads to address and escalate IMP quality issues.
- Support supplier audits and ensure readiness for Health Authority GMP inspections.
Qualifications:
- Bachelor's degree or equivalent education/degree in life sciences.
- Solid understanding of the GMP & GDP and GCP requirements in support of IMP study.
- Minimum 10 years of experience within pharmaceutical, biotech product.
- Relevant experience from working with quality aspects of medicinal products in clinical trials, especially batch allocation and supply to clinical trials.
- Extensive experience in QA operation, production or other relevant area (GMP, GDP).
- Strong working knowledge of US and European regulations, with emphasis on Annex 13, and preferably other regions such as APAC and LATAM.
- Strong understanding of risk assessment and risk management fundamentals/tools.
- Fluently spoken and written English.
About Us:
Sobi is a global company with over 1,800 employees in more than 30 countries. We are committed to the societies where we operate and are dedicated to making a positive impact on the lives of people with rare diseases.
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