Associate Director Clinical Quality Assurance and GxP Compliance

Location: Novato, CA or South San Francisco, CA, United States. Flex hybrid work model with onsite presence typically required 2–3 days per week or more based on business needs; approximately 30% travel may be required.

Annual salary: $199,200–$246,100 USD, plus eligibility for annual bonus and equity incentives.

Company

hirify.global is a biopharmaceutical company developing innovative treatments for rare diseases.

What you will do

• Lead the development and continuous improvement of clinical quality assurance strategies, policies, programs, and initiatives.
• Provide strategic oversight of GCP audits, including complex, high-risk, for-cause, and systemic failure evaluations.
• Represent Clinical Quality during regulatory inspections and oversee inspection narratives, storyboards, issue presentation, and cross-functional coordination.
• Direct enterprise clinical program inspection readiness, including risk-based vendor and site assessments, mock inspections, war room preparation, and governance.
• Advise functional leaders on FDA, EMA, and ICH-GCP requirements, non-compliances, risk areas, and sustainable corrective solutions.
• Lead quality initiatives and continuous improvement programs while serving as a liaison to Records & Document Management and Site Management Liaison teams.

Requirements

• Bachelor’s degree in a scientific or related technical discipline.
• At least 7 years of experience in healthcare, biotechnology, or the pharmaceutical industry, including 3–6 years of quality assurance or compliance experience preferred.
• Direct experience leading or organizing regulatory authority inspections.
• Expertise in U.S. FDA, EMA, and ICH-GCP regulations and clinical quality systems.
• Ability to establish and execute quality goals over a forward-looking 3–5 year period.
• Strong written and verbal communication, strategic thinking, flexibility, collaboration, coaching, and mentoring skills.

Culture & Benefits

• Supportive and inclusive environment focused on learning, growth, and quality excellence.
• Generous vacation time and company-observed public holidays.
• Volunteer days and employee wellbeing benefits.
• Long-term incentive and employee stock purchase plans or equivalent offerings.
• Fitness reimbursement, tuition sponsorship, and professional development plans.