Director of Clinical QA (Biopharma)

Location: San Carlos, California; remote candidates may be considered. The compensation range applies to candidates across United States job markets.

Salary: $190,000–$225,000 per year, plus equity incentive awards and employer-sponsored benefits.

Company

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

What you will do

• Lead inspection-readiness activities and support the preparation, conduct, and response to regulatory authority inspections.
• Develop and execute annual risk-based audit plans covering vendors, investigator sites, study databases, partners, and internal clinical teams.
• Maintain and improve clinical quality systems, controlled documents, procedures, and GxP processes.
• Provide GCP and regulatory compliance support to Clinical Operations, Data Management, and study execution teams.
• Review clinical-trial documents, conduct gap analyses and risk assessments, and lead investigations into non-compliance.
• Manage audit findings, root-cause analysis, CAPA plans, effectiveness checks, consultants, and applicable junior CQA staff.

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 CQA quality roles with increasing responsibility.
• At least 5 years of experience leading or independently conducting CQA audits and managing audit CAPA activities.
• Expert knowledge of ICH GCP guidelines and FDA regulations, including BIMO inspection readiness.
• Knowledge of Computer System Validation requirements related to CQA audits.
• Strong communication, relationship-building, prioritization, problem-solving, and stakeholder-influence skills; proficiency with Microsoft Office tools.

Culture & Benefits

• Collaborative work with internal clinical and nonclinical groups, consultants, CROs, service providers, and investigator sites.
• Competitive cash compensation, equity incentive awards, and employer-sponsored benefits.
• Work focused on quality, transparency, open communication, continuous improvement, and teamwork.