Manager Quality Assurance
Scorpion Therapeutics
Role: Manager, Quality Assurance overseeing external manufacturers of Advanced Therapy products, ensuring compliance with safety, regulatory, and quality standards.
Responsibilities
- lead quality systems and controls
- manage partner qualification and monitoring
- resolve quality issues with CAPA plans
- review and approve quality documentation
- analyze metrics for risks and improvements
- foster relationships with partners
- support inspections and compliance
- and drive continuous improvement and tech transfer activities
Requirements
- 8+ years in an FDA/EMA-regulated environment
- bachelor's in a scientific or technical discipline
- extensive QA/QC and compliance knowledge
- familiarity with GMP, biologics, aseptic manufacturing, and Good Tissue Practices
Preferred: strong analytical skills and experience with regulatory communications.
High-value: biologics, aseptic processes, biologics products, external manufacturing oversight, regulation compliance, and cross-functional stakeholder influence.
Work setup: based in New Jersey or Pennsylvania, with up to 30% travel.
Position emphasizes leadership in quality assurance for complex biopharma manufacturing, ensuring product integrity and regulatory readiness.
#J-18808-LjbffrVacancy posted 4 days ago
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