Biopharma QA Leader – External Manufacturing & Compliance

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

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.