Sr/Exec Director, Quality Assurance GCP

Overview

In this high-impact leadership role reporting to the Chief Operating Officer, you will serve as the strategic head of GCP Quality Assurance for a clinical-stage oncology organization. You will be responsible for the oversight and implementation of QA operations across all phases of clinical development, ensuring that global trials and regulatory submissions meet the highest standards of compliance as the company prepares for commercial launch.

Responsibilities

• Lead all strategic and tactical clinical quality oversight for global Phase 1 through Phase 3 clinical programs.
• Establish and maintain quality policies to ensure systems align with global health authority regulations including GCP, GVP, and GLP.
• Develop and execute a risk-based GCP audit program and compliance strategy for all internal and external clinical study activities.
• Represent the clinical quality function during global regulatory inspections and lead the preparation of sites and staff for health authority audits.
• Oversee study documentation and Trial Master Files to ensure accuracy, compliance, and constant inspection readiness.
• Manage and mentor a team of quality professionals while providing guidance to cross-functional partners on regulatory risk and process improvements.
• Collaborate with external vendors and service providers to ensure their quality programs meet company standards and international guidelines.

Qualifications

• You must have at least 12 years of experience in GCP Quality roles within a pharmaceutical or biotechnology environment.
• You have a proven track record of managing quality for registrational clinical trials through the drug approval process.
• You possess extensive experience participating in and leading regulatory agency inspections on a global scale.
• You hold deep expertise in ICH GCP guidelines and a comprehensive understanding of FDA, EMA, and other global regulatory requirements.
• You have demonstrated leadership experience, including the ability to manage direct reports and influence senior stakeholders.
• You possess a bachelor's degree in Biology, Chemistry, or a related physical science discipline.

Nice to have

• Experience transitioning a company from clinical-stage to commercial-stage quality systems is highly preferred.
• Additional expertise in oversight for GVP, GLP, and Companion Diagnostics (CDx) activities is an advantage.
• Advanced knowledge of specific global health authority requirements from agencies such as Health Canada and PMDA is beneficial.

Work environment

• This position is based in San Diego, California, with a work arrangement that supports remote flexibility.
• You will work in a fast-paced, clinical-stage environment that emphasizes collaborative and science-driven decision-making.
• The role involves significant interaction with global sites, requiring you to manage quality across various time zones and regulatory jurisdictions.
• You will operate as a key member of the Quality Assurance leadership team in a professional, mission-oriented setting.

Benefits & growth

• The annual base salary range for this leadership position is $250,000 to $290,000.
• You are eligible for an annual performance bonus and equity grants in the form of stock options.
• The package includes comprehensive health, dental, and vision plans, along with a 401(k) plan featuring company contributions.
• You can take advantage of unique perks such as pet insurance, an employee stock purchase program, and flexible spending accounts.
• This role offers significant career growth as you build out the QA department and lead the transition toward commercial product launches.