Cell Therapy Production Compliance Specialist
2 semanas atrás
This is a key role in our Cell Therapy Manufacturing team. The External Quality Assurance (EQA) Specialist will provide critical oversight of Contract Development and Manufacturing Organizations (CDMOs) and testing laboratories to ensure compliance with cGMP, regulatory requirements, and company quality standards.
- Review and approve deviations, Out-of-Specification (OOS) investigations, CAPAs, and change controls from CDMOs and external testing laboratories.
- Monitor manufacturing campaigns, production activities, and resolve issues during routine manufacturing.
- Review and approve QC/analytical results and Certificates of Analysis from CDMOs/external labs.
- Review and approve production lot records for compliance prior to disposition.
- Perform GMP reviews of incoming documentation (batch records, test data, release packages).
- Ensure timely escalation and resolution of manufacturing and quality issues.
- Collaborate with internal cross-functional teams (QA, QC, Supply Chain, Regulatory, CMC) to ensure readiness for release and regulatory filings.
- Support audit readiness activities for Regulatory Authority inspections.
- Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Engineering, or related discipline.
- 3–5 years of QA experience in the biopharmaceutical or cell/gene therapy industry.
- Strong knowledge of cGMP, ICH Q7/Q10, FDA 21 CFR Parts 210/211.
- Experience with CDMO oversight, lot release, and deviation management.
- Excellent communication and problem-solving skills.
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