Director, Quality Assurance

Scorpion Therapeutics; Foster City (CA); On-site; USD 220,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks a Director of Quality Assurance to provide global oversight of GMP QA operations across development and commercialization, ensuring product quality, regulatory compliance, and continuity of clinical and commercial supply.

You will lead cross-functional QA activities, support labeling, investigations, CAPA, and regulatory submissions while interfacing with authorities and CMOs. Travel up to 20% is expected.

Qualifications

• Bachelor’s degree in a scientific discipline is required; MS/PhD preferred.
• 10+ years in pharma/biotech; 8+ years in GMP Quality Assurance.
• Experience in clinical or commercial labeling and last-mile commercial operations.
• Strong knowledge of global GMP/GDP (FDA, EU GMP EudraLex Vol 4, ICH) and distribution requirements.
• Regulatory submission and health authority inspection experience (including PAIs).

Responsibilities

• Provide QA oversight of finished product (FP) and of drug substance/drug product (DS/DP) across the development lifecycle.
• Oversee clinical and commercial distribution activities under GDP/DSCSA/serialization/track-and-trace/exception management requirements.
• Support commercial labeling development/approval (prepress, proofreading, anti-counterfeiting).
• Perform lot disposition (batch record review; in-process/release/stability testing).
• Review/approve protocols and reports for technology transfer, process validation, method transfer/qualification/validation, and expiry dating.
• Lead investigations, risk assessments, and change controls; ensure quality issues are evaluated and justified.
• Provide technical guidance for deviations, laboratory investigations, and quality events; ensure tracking and timely resolution.
• Prepare/review/approve Quality Agreements with GxP vendors/sites/partners/IST partners.

Skills

Quality Assurance

GMP

Regulatory compliance

Leadership

Problem-solving

Risk management

Communication

Cross-functional collaboration

Education

Bachelor’s degree in a scientific discipline

MS/PhD preferred

Job description

Position Summary

The Director, Quality Assurance provides global oversight and management of GMP Quality Assurance operations supporting development and commercial programs, including technical/compliance leadership, resolution of quality issues, cross-functional collaboration, and oversight of product quality, regulatory compliance, and continuity of clinical/commercial supply. Oversees clinical and commercial GDP activities, including U.S., EU/UK, and global GDP requirements (including U.S. DSCSA, serialization, track-and-trace, and exception management).

Responsibilities

• Provide QA oversight of finished product (FP) and of drug substance/drug product (DS/DP) across the development lifecycle.
• Oversee clinical and commercial distribution activities under applicable GDP/DSCSA/serialization/track-and-trace/exception management requirements.
• Support commercial labeling development/approval (prepress, proofreading, anti-counterfeiting).
• Perform lot disposition (batch record review; in-process/release/stability testing; assess quality events).
• Review/approve protocols and reports for technology transfer, process validation, method transfer/qualification/validation, and expiry dating.
• Lead investigations, risk assessments, and change controls; ensure quality issues are evaluated, addressed, documented, and justified.
• Provide technical guidance for deviations, laboratory investigations, and quality events; ensure tracking and timely resolution.
• Author/review/negotiate Quality Agreements with GxP vendors/sites/partners/IST partners.
• Prepare/review/approve APR/PQRs (as applicable).
• Conduct compliance gap assessments and drive remediation to completion.
• Communicate manufacturing deficiencies/nonconformances and ensure timely resolution.
• Support regulatory submissions and documentation (IND, CTA, IMPD, NDA, MAA) and inspections (including PAIs).
• Interface with regulatory authorities and host third-party GMP audits; support CMO pre-approval inspections.
• Champion continuous improvement initiatives.
• Travel up to 20% (including international).

Qualifications

• Bachelor’s degree in a scientific discipline required; MS/PhD preferred.
• 10+ years in pharma/biotech; 8+ years in GMP Quality Assurance.
• Required: experience in clinical and/or commercial labeling and last-mile commercial operations.
• Strong knowledge of global GMP/GDP (FDA, EU GMP EudraLex Vol 4, ICH) and clinical/commercial distribution requirements.
• Demonstrated experience from early development through global commercialization.
• Strong CMC/process validation/technology transfer knowledge and small-molecule manufacturing exposure.
• Regulatory submission and health authority inspection experience (including PAIs).
• Experience overseeing international CMOs, CTLs, CPOs, 3PLs, and distributors.
• Preferred: global serialization/track-and-trace and DSCSA exception management.
• Excellent communication, collaboration, leadership, problem-solving, and risk management skills.

Compensation

• Salary range: $220,000–$240,000 USD (base salary only as stated).

Travel

• Up to 20% (including international).