Sr/Exec Director, Quality Assurance GCP

Overview

In this executive leadership role reporting directly to the Chief Operating Officer, you will direct Good Clinical Practice (GCP) quality assurance operations across all phases of clinical development, regulatory submissions, and preparation for commercial launch. You will serve as a core leader within the Quality Assurance organization, driving strategic quality oversight for global Phase 1 through Phase 3 oncology clinical trials while ensuring stringent compliance across GCP, GLP, GVP, and CDx frameworks. You will be responsible for building and executing a risk-based clinical audit program, managing external auditors, and leading global health authority inspection readiness and execution. Partnering closely with Clinical Operations, Development, and GMP Quality teams, you will establish robust quality policies, resolve critical compliance issues, oversee CAPA implementations, and mentor a high-performing quality assurance and inspection team.

Responsibilities

• Lead strategic and tactical GCP quality assurance oversight across all phases of clinical development, regulatory filings, and future commercial launches.
• Develop and execute a comprehensive, risk-based GCP audit program and manage third-party auditors and vendor compliance.
• Prepare, lead, and represent the organization during global regulatory inspections across internal sites and global clinical investigator sites.
• Perform compliance and risk-focused technical reviews of key clinical study documents, including protocols, investigator brochures, ICFs, DSURs, and CSRs.
• Collaborate with Clinical Operations to oversee Trial Master File (TMF) integrity, accuracy, and continuous inspection readiness.
• Track, compile, and analyze clinical quality KPIs and vendor performance metrics to deliver actionable reports to executive leadership.
• Investigate quality events, protocol deviations, and potential serious breaches while driving appropriate corrective and preventative action (CAPA) plans.

Qualifications

• At least 12 years of progressively responsible GCP quality assurance experience within the biotechnology or pharmaceutical industry.
• Demonstrated experience managing quality assurance for registrational clinical trials and navigating global regulatory inspections.
• Deep expertise in ICH GCP guidelines (E6, E8, E2F, E3) along with FDA, EMA, Health Canada, and PMDA regulatory frameworks.
• Proven leadership capability with experience establishing clinical quality policies, audit strategies, and CAPA processes.
• Strong communication and influencing skills with the ability to represent quality operations across executive leadership and global health authorities.

Nice to have

• An undergraduate or advanced degree in Biology, Chemistry, Life Sciences, or a related scientific discipline.
• Direct experience transitioning quality systems from clinical-stage operations to commercial readiness.
• Working knowledge and oversight experience spanning GVP, GLP, and companion diagnostics (CDx) quality requirements.

Work environment

• The role offers a remote-friendly work arrangement based out of the San Diego, California headquarters.
• Standard full-time schedule of approximately 40 hours per week, with flexibility required during active regulatory audits and filings.
• Highly collaborative, patient-centric, and fast-paced precision oncology research and clinical development environment.

Benefits & growth

• Base salary range between $250,000 and $290,000 per year, commensurate with experience and qualifications.
• Eligibility for an annual performance bonus and initial plus ongoing equity grant options.
• Comprehensive health benefits including medical, dental, vision, life, AD&D, and disability insurance plans.
• 401(k) retirement savings plan with company matching contributions and an Employee Stock Purchase Program (ESPP).
• Generous paid time off, company holidays, sick leave, flexible spending accounts, and pet insurance options.