Job Summary
The External Quality Assurance Manager plays a critical role in ensuring that quality and compliance standards are met throughout the external manufacturing and supply chain. This includes oversight of Contract Manufacturing Organizations (CMOs) and suppliers to guarantee adherence to both regulatory standards and internal company protocols.
Responsibilities
- Conduct risk-based audits of external manufacturing and supply chain entities.
- Address and manage quality-related events and issues that arise.
- Ensure compliance with regulatory requirements and company quality standards among external partners.
Qualifications
- A degree in Pharmacy, Life Sciences, Chemistry, or a related field is essential.
- Significant experience in pharmaceutical quality assurance is required.
- Proficient understanding of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and international pharmaceutical regulations is crucial.
