Manager Quality Assurance

Scorpion Therapeutics; New Jersey; Hybrid; USD 150,000 - 210,000; Full time

Job summary

Scorpion Therapeutics is seeking a Manager of Quality Assurance to oversee external manufacturing for Advanced Therapy products. You will ensure safety, regulatory, and quality standards are met while leading quality systems and supplier oversight.

The role requires 8+ years in FDA/EMA-regulated environments, a science/engineering degree, and deep GMP, QC, and tissue-based manufacturing expertise. Hybrid work in NJ/PA with up to 30% travel is expected.

Qualifications

• 8+ years in FDA/EMA-regulated environments.
• Bachelor's degree in a scientific or technical field.
• Strong QA, QC, and compliance knowledge.
• Background in biologics, aseptic manufacturing, and Good Tissue Practices.

Responsibilities

• Lead quality systems for external manufacturing of Advanced Therapy products.
• Qualify and monitor external partners to ensure GMP compliance.
• Investigate and resolve quality issues and non-conformances.
• Review batch records, deviations, CAPAs and change controls.
• Monitor metrics for risk management and drive continuous improvements.

Skills

QA leadership

Regulatory communication

Stakeholder management

GMP/compliance

Education

Bachelor's degree in science or engineering

Job description

Role

Manager of Quality Assurance overseeing external manufacturing for Advanced Therapy products, ensuring compliance with safety, regulatory, and quality standards. Responsibilities include leading quality systems, qualifying and monitoring external partners, investigating and resolving quality issues, reviewing documentation, analyzing metrics for risk management, fostering relationships with stakeholders, supporting inspections, and driving continuous improvements.

Experience & Qualifications

8+ years in FDA/EMA-regulated environments, Bachelor's in a scientific or technical field; extensive QA, QC, and compliance knowledge. Must have background in biologics, aseptic manufacturing, and Good Tissue Practices. Skills in regulatory communication and stakeholder influence are preferred.

High-Value Details

Focus on biologics/Advanced Therapy, experience with GMP, tissue/biosafety standards, and external partner oversight in commercial manufacturing; potential involvement in tech transfer and new product launches.

Work Setup

Location in New Jersey or Pennsylvania (prefer Raritan, NJ), hybrid/remote, with up to 30% travel. The role emphasizes leadership, cross-functional collaboration, and maintaining inspection readiness and compliance across manufacturing sites.