Director, Clinical Quality Assurance - Contractor

Location: South San Francisco, CA, United States; onsite Tuesday–Thursday. Approximately 15% travel is required.

Salary: $193,000–$242,000 USD annually, with stock options and an annual bonus program.

Company

hirify.global is a precision medicines company developing treatments intended to improve outcomes for patients with autoimmune diseases.

What you will do

• Establish and maintain ICH-GCP clinical quality assurance programs, policies, procedures, and study-specific audit plans.
• Provide ICH-GCP/GVP quality oversight across ongoing clinical programs and act as the primary subject matter expert for assigned studies.
• Perform audits, lead external quality auditors, review clinical and IND/NDA-enabling documentation, and assess data integrity and compliance.
• Support inspection readiness, health authority inspections, service-provider oversight, and CRO operational meetings.
• Establish key performance indicators and compliance metrics, conduct root cause analysis, and develop risk mitigations.
• Provide operational quality guidance to development teams and support the Quality organization’s strategy and vision.

Requirements

• Bachelor’s or advanced degree in Biology, Chemistry, or a related field.
• Minimum 10 years of ICH-GCP/GVP quality assurance experience, including clinical trial auditing.
• Extensive knowledge of FDA regulations, ICH guidance, and global health authority regulations and practices.
• Experience with quality management systems, drug life cycle management, service providers, CROs, and pharmaceutical quality systems.
• Direct experience with small-molecule products and solid oral dosage forms.
• Prior management experience, cross-functional leadership, strong communication skills, and the ability to make sound decisions in complex and ambiguous situations.

Culture & Benefits

• Collaborative environment focused on transforming patients’ lives through precision medicines.
• Health insurance premiums covered at 90% for employees and 80% for dependents.
• Unlimited PTO for exempt employees.
• Free onsite gym and kitchen stocked with snacks and drinks.
• Free access to the Genentech Bus & Ferry Share program and a $100 monthly cell phone stipend.