Director of Clinical QA (Biopharmaceutical)

Location: San Carlos, California, United States; remote candidates may be considered

Salary: $190,000–$225,000 per year

Company

hirify.global is a privately held, clinical-stage biopharmaceutical company developing antibody therapeutics for oncology, autoimmune disorders, neurology, and other serious diseases.

What you will do

• Lead clinical quality assurance activities across domestic and international development programs using a risk-based quality management approach.
• Develop and execute annual GCP audit plans covering vendors, investigator sites, study databases, internal clinical teams, and other partners.
• Support inspection readiness and the preparation, conduct, and response to regulatory authority inspections.
• Review clinical trial documents, including protocols, informed consent forms, investigator brochures, annual reports, clinical study reports, and study plans.
• Lead or support audits, investigations, root-cause analyses, corrective and preventive actions, and effectiveness checks.
• Collaborate with Clinical Operations, Data Management, clinical study execution teams, consultants, CROs, service providers, and investigator sites.

Requirements

• Bachelor of Science degree in a scientific, life science, medical, or technical discipline.
• At least 10 years of pharmaceutical industry experience, including 8 years in GCP or clinical quality assurance roles with increasing responsibility.
• At least 5 years of experience independently leading or performing CQA audits and managing audit CAPAs.
• Expert knowledge of ICH GCP guidelines, FDA regulations, and applicable GxP requirements.
• Experience with BIMO inspections, inspection readiness, and Computer System Validation requirements related to CQA audits.
• Strong written and verbal communication, stakeholder management, prioritization, and problem-solving skills.

Culture & Benefits

• Competitive cash compensation and equity incentive awards.
• Employer-sponsored benefits.
• Work arrangement based in San Carlos, with remote candidates considered.
• Equal opportunity employment based on merit and business needs.