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4 hours ago
The Clinical Quality Assurance Manager will oversee the quality and compliance of Investigational Medicinal Products (IMPs) through leadership and guidance of supplier management teams.
Key Responsibilities:
- Ensure quality assurance and compliance across all aspects of IMPs.
- Develop and implement quality systems and procedures to ensure efficient delivery of high-quality IMPs.
- Collaborate with cross-functional teams to identify and mitigate quality risks associated with IMPs.
- Oversee the review and release of batch records for IMPs across various clinical trials.
- Manage key performance indicators (KPIs) related to IMP supplier quality and implement corrective actions as necessary.
- Ensure compliance with Quality Agreements and support revisions in collaboration with internal teams.
- Support supplier audits and ensure readiness for Health Authority GMP inspections.
To be successful in this role, you will have:
- 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.
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