
Quality Assurance Lead Clinical Trials
1 day ago
We are seeking an experienced Clinical Quality Assurance Manager to join our team at Sobi, Inc. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and leadership.
The Clinical Quality Assurance Manager will be responsible for ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) throughout their lifecycle. This includes developing and implementing quality strategies, managing supplier relationships, and ensuring adherence to regulatory requirements.
Key Responsibilities
- Develop and implement quality strategies to ensure the quality and compliance of IMPs.
- Manage supplier relationships to ensure timely delivery of high-quality IMPs.
- Ensure adherence to regulatory requirements, including GMP & GDP and GCP.
- 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.
Required Skills and Qualifications
- Bachelor's degree or equivalent education/degree in life sciences.
- 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 the Role
- This is an exciting opportunity to join a dynamic team at Sobi, Inc.
- You will have the chance to make a meaningful contribution to the development of high-quality Investigational Medicinal Products (IMPs).
- You will work closely with cross-functional teams to ensure the quality and compliance of our IMPs.
- You will have opportunities for professional growth and development.
Company Overview
Sobi, Inc. is a leading developer of Investigational Medicinal Products (IMPs). Our mission is to deliver high-quality products that meet the needs of patients worldwide.
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