Director, GMP Quality Assurance

Scorpion Therapeutics; Foster City (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics in Foster City, CA seeks a Director of GMP Quality Assurance to lead global quality operations for development and commercial biologics products. The role covers finished goods, batch release, and documentation for regulatory submissions and inspections.

You will drive investigations, change controls, and risk assessments, ensuring compliance with FDA, EU GMP, and DSCSA, while coordinating audits and regulatory interactions on a global scale.

Qualifications

• Bachelor's in a scientific discipline.
• 10+ years in pharma/biotech with 8+ years in GMP QA.
• Extensive knowledge of GMP/GDP regulations, CMC, process validation, and global supply chain.
• Experience supporting regulatory submissions, inspections, and international contract manufacturing.
• Strong leadership, communication, and risk management skills.

Responsibilities

• Oversee QA for finished products from development through commercialization, including clinical and commercial distribution compliance, batch review, and product release.
• Lead investigations, change controls, risk assessments, and GMP/GDP activities oversight.
• Author and review technical and regulatory documentation supporting submissions and inspections.
• Ensure compliance with FDA, EU GMP, and DSCSA; interface with regulatory authorities and oversee third-party audits.

Skills

Leadership

Communication

Risk management

Education

Bachelor's in a scientific discipline

Tools

GMP/GDP regulations

CMC knowledge

Process validation

Global supply chain

Job description

Role

Director of GMP Quality Assurance overseeing global quality operations for development and commercial biopharmaceutical products.

Responsibilities

• manage quality assurance for finished products from early development through commercialization, including clinical and commercial distribution compliance, batch review, and product release
• lead investigations, change controls, risk assessments, and oversight of GMP and GDP activities
• author and review technical and regulatory documentation supporting submissions and inspections
• ensure compliance with global regulations such as FDA, EU GMP, and DSCSA
• interface with regulatory authorities and oversee third-party audits

Requirements

• Bachelor's in a scientific discipline
• 10+ years in pharma/biotech, with 8+ years in GMP QA
• extensive knowledge of GMP/GDP regulations, CMC, process validation, and global supply chain
• experience supporting regulatory submissions, inspections, and international contract manufacturing
• strong leadership, communication, and risk management skills

High Value

• GMP QA leadership
• global distribution compliance
• product lifecycle support from early development to commercialization
• experience with serialization and traceability
• regulatory interaction
• inspection readiness

Work Setup: travel up to 20%, including international.