Manager Quality Assurance

Scorpion Therapeutics; Raritan (NJ); Hybrid; USD 120,000 - 160,000; Full time

Job summary

Scorpion Therapeutics seeks a Manager, Quality Assurance to oversee external manufacturing of Advanced Therapy products. You will ensure compliance with safety, regulatory, and quality standards across partner facilities.

The role requires leading quality systems, monitoring partners, managing investigations, and reviewing validation and technical docs. Hybrid setup with travel up to 30% in NJ/PA; strong QA focus and regulatory collaboration.

Qualifications

• 8+ years in FDA/EMA-regulated environments.
• Bachelor’s in science or related field.
• Extensive QA/QC knowledge.
• Experience with biologics, aseptic manufacturing, and Good Tissue Practices.
• Strong communication skills.

Responsibilities

• Lead quality systems and compliance programs across external manufacturing partners.
• Oversee partner qualification and ongoing monitoring.
• Manage investigations and CAPA related to manufacturing.
• Review validation and technical documentation.
• Analyze metrics for risk mitigation and drive continuous improvement.
• Foster relationships with external partners and support inspections readiness.
• Drive regulatory compliance and continuous improvement initiatives.

Skills

Quality Assurance

Regulatory compliance

QA/QC knowledge

GxP compliance

Communication skills

Education

Bachelor's degree in Science or related field

Job description

Role: Manager, Quality Assurance overseeing external manufacturing of Advanced Therapy products, ensuring compliance with safety, regulatory, and quality standards.

Responsibilities: lead quality systems, oversee partner qualification and monitoring, manage investigations, review validation and technical documentation, analyze metrics for risk mitigation, foster relationships with partners, support inspection readiness, and drive continuous improvement initiatives.

Qualifications: 8+ years in FDA/EMA-regulated environments; Bachelor’s in science or related field; extensive QA/QC knowledge; experience with biologics, aseptic manufacturing, and Good Tissue Practices; strong communication skills.

Preferred: analytical skills and regulatory writing experience.

High-Value: biologics, Advanced Therapy, external manufacturing oversight, compliance with GxP and regulatory inspections.

Work Setup: hybrid with up to 30% travel; locations in New Jersey or Pennsylvania.