Manager Quality Assurance

Scorpion Therapeutics; Horsham (PA); On-site; USD 145,000 - 210,000; Full time

Job summary

Scorpion Therapeutics in Horsham, PA seeks a Manager, Quality Assurance to oversee external manufacturers of Advanced Therapy products. You will lead quality systems, ensure regulatory readiness, and drive product integrity across complex biopharma collaborations.

The role requires 8+ years in FDA/EMA-regulated environments, a BS in a scientific or technical field, and deep QA/QC expertise with GMP and aseptic biologics.

Qualifications

• 8+ years in an FDA/EMA-regulated environment.
• Extensive QA/QC and regulatory compliance knowledge.
• Familiarity with GMP, biologics, aseptic manufacturing, and Good Tissue Practices.
• Strong analytical skills and regulatory communications experience.

Responsibilities

• Lead quality systems and controls across external manufacturers.
• Manage partner qualification and monitoring programs.
• Resolve quality issues with CAPA plans and timely closure.
• Review and approve quality documentation and change controls.
• Analyze metrics to identify risks and drive improvements.
• Foster relationships with partner organizations and suppliers.
• Support inspections, regulatory readiness, and compliance activities.
• Drive continuous improvement and tech transfer activities.

Education

Bachelor's degree in a scientific or technical discipline

Job description

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.