Director, Quality Assurance (Gene Therapy Biotech)

We're hiring a Director, Quality Assurance to join the team at Opus Genetics in Durham, NC.

This is a hands-on QA leadership role sitting at the intersection of Clinical and CMC - you'll own GxP compliance, supplier quality, inspection readiness, and the quality systems that support our AAV gene therapy pipeline from the lab bench to the clinic.

What you'll be doing:

Quality Leadership & Quality Management System

• Provide risk-based QA leadership across Clinical Development and CMC activities.
• Maintain and continuously improve the Pharmaceutical Quality System (Document Control, Training, Deviations, Investigations, CAPA, Change Control, Audits, Supplier Quality, and Management Review).
• Ensure quality processes are compliant, documented, and supported by metrics and trend analysis.
• Provide QA guidance on cross-functional decisions and escalate quality or compliance risks.
• Support validation and compliant use of electronic systems, including Data Integrity, Audit Trails, Electronic Signatures, Access Controls, and Records Retention.

Clinical Quality Assurance

• Provide GCP QA oversight focused on participant protection, data reliability, Quality by Design, and Risk-Based Quality Management.
• Oversee CROs and clinical vendors through risk assessments, audits, Quality Agreements, performance monitoring, issue escalation, and CAPA management.
• Review Clinical Quality Plans, Vendor Oversight Plans, TMF Plans, Protocol Deviations, and other controlled clinical documentation.
• Partner with Clinical Operations to identify critical-to-quality factors, manage risks, and document sponsor oversight.
• Conduct routine, risk-based, and for-cause GCP audits.
• Support TMF quality, inspection readiness, mock inspections, regulatory inspections, and response development.
• Lead investigations, root-cause analysis, CAPAs, and effectiveness assessments for significant quality events.

CMC & Supplier Quality Assurance

• Provide QA oversight of CDMOs, contract laboratories, and other GxP suppliers supporting manufacturing, testing, storage, release, and distribution.
• Lead GCP, GMP and GLP supplier qualification, risk classification, audits, requalification, and performance monitoring.
• Develop, review, and maintain Quality Agreements, Technical Agreements, and quality-related Statements of Work.
• Review supplier deviations, investigations, OOS/OOT results, change controls, CAPAs, validation documents, and critical quality records.
• Review Certificates of Analysis for accuracy, traceability, and compliance.
• Support product disposition and release decisions while maintaining Quality Unit independence.
• Apply Data Integrity and ALCOA+ principles during supplier audits and document reviews.

Inspection Readiness & Compliance

• Maintain inspection-ready documentation for Clinical and CMC activities.
• Support FDA, health authority, partner, and due diligence inspections, including preparation, coordination, observation management, and responses.
• Monitor changes to GCP, GMP, Electronic Records, Data Integrity, and Supplier Quality requirements.
• Promote a culture of quality, accountability, transparency, and timely escalation.

People Leadership & Collaboration

• Serve as a trusted quality partner while maintaining independent quality judgment.
• Train and coach employees and contractors on GxP requirements, inspection readiness, and risk-based decision-making.
• Lead cross-functional quality initiatives and document decisions, action items, owners, and due dates.
• Manage and develop Quality team members, including prioritization, goal setting, and performance management, as applicable.

What we're looking for:

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, or a related discipline.
• 10+ years of progressive Quality Assurance experience in the pharmaceutical, biotechnology, biologics, or gene therapy industry.
• Experience supporting both clinical-stage programs and CMC/GMP activities, including outsourced development and manufacturing models.
• Experience with GCP vendor oversight, clinical audits, TMF quality, CAPA management, and inspection readiness.
• Experience with supplier qualification, CDMO and contract laboratory audits, Quality Agreements, investigations, change controls, and CMC documentation.
• Experience supporting regulatory inspections, partner audits, and due diligence assessments.
• Working knowledge of FDA regulations and guidance, including 21 CFR Parts 11, 50, 54, 56, 58, 210, 211, and 312.
• Knowledge of ICH E6(R3), ICH Q9, ICH Q10, Data Integrity principles, and Risk-Based Quality Management.
• Ability to interpret regulations and translate requirements into practical, phase-appropriate quality controls.
• Strong audit, investigation, root cause analysis, CAPA, technical writing, and document review skills.
• Ability to assess risk, make sound quality decisions, and effectively communicate recommendations to leadership and external partners.
• Strong collaboration, influencing, and independent decision-making skills.
• Excellent organizational, prioritization, attention to detail, and follow-through skills.
• Proficiency with Microsoft 365 and electronic quality, document management, training, and clinical systems.

Preferred:

• Advanced degree (MS, PharmD, PhD, or equivalent) or relevant professional certification.
• Experience implementing or administering an Electronic Quality Management System (eQMS).
• Prior people management or matrix leadership experience.
• Experience building, scaling, or enhancing Quality Systems within a growing biotechnology company.
• Experience supporting gene therapy, cell therapy, biologics, or other advanced therapeutic development programs.

Location: Durham, NC (Hybrid) — Remote considered, East Coast preferred

Salary: $210,000–$225,000

If you've built or strengthened quality systems at a clinical-stage biotech and want to do meaningful work in rare disease and gene therapy, I'd love to connect.