Director, GMP QA Operations

Scorpion Therapeutics; California (MO); On-site; USD 211,000 - 264,000; Full time

Job summary

Scorpion Therapeutics seeks a Director of GMP QA Operations to oversee quality assurance for clinical and commercial oncology products. You will lead QA across external manufacturing networks, including Drug Substance, Drug Product, and Finished Product, ensuring product quality and regulatory readiness.

You will review batch records, deviations, investigations, and dispositions while driving GMP compliance and risk management.

Qualifications

• 12+ years in GMP Quality with leadership experience.
• 5+ years managerial experience.
• Experience supporting small molecule manufacturing, especially oral solid dosage forms.

Responsibilities

• lead QA activities across external manufacturing, including Drug Substance, Drug Product, and Finished Product
• review batch records, deviations, investigations, and batch disposition
• ensure GMP compliance, inspection readiness, and quality risk management
• support regulatory filings, inspections, and lifecycle activities
• provide leadership and mentorship to QA teams

Skills

GMP Quality

Leadership/Management

External manufacturing oversight

Regulatory compliance

Education

Bachelor's in a scientific/technical discipline

Job description

Role

Director of GMP QA Operations overseeing quality assurance for clinical and commercial products in an oncology-focused biopharma.

Responsibilities

• lead QA activities across external manufacturing, including Drug Substance, Drug Product, and Finished Product
• review batch records, deviations, investigations, and batch disposition
• ensure GMP compliance, inspection readiness, and quality risk management
• support regulatory filings, inspections, and lifecycle activities
• provide leadership and mentorship to QA teams

Requirements

• Bachelor's in a scientific/technical discipline
• 12+ years in GMP Quality, with 5+ years managerial experience
• extensive support of small molecule manufacturing, especially oral solid dosage forms
• strong knowledge of GMP regulations, batch release, and external partner oversight

Preferred

• experience with commercial batch disposition, global supply, and post-approval lifecycle

HighValue

GMP quality oversight for small molecule manufacturing, clinical to commercial phases, supporting external manufacturing networks, and regulatory compliance within oncology drug development.

WorkSetup

on-site in Redwood City, CA, with a salary range of $211,000-$264,000 USD.