Director, Clinical Quality Assurance (GCP)

Location: Hybrid, with a minimum of 3 days per week onsite at either the Jersey City, NJ or Millbrae, CA office. Travel up to 50% domestically and internationally may be required.

Salary: $204,000–$246,750 per year, plus bonus and equity compensation.

Company

hirify.global Therapeutics is a biopharmaceutical company developing treatments for life-threatening diseases through a platform combining chemistry, engineering, computation, biology, and molecular-resolution live-cell microscopy.

What you will do

• Lead and manage the Clinical Quality Assurance audit program covering internal, clinical site, and vendor audits.
• Develop risk-based audit plans, conduct clinical trial audits, and deliver accurate audit reports.
• Lead quality management system assessments and support qualification of clinical service providers.
• Advise cross-functional teams on GCP compliance, protocol adherence, regulatory requirements, deviations, and non-compliance events.
• Review and approve essential study documents, including protocols, informed consent forms, and clinical study reports.
• Own inspection-readiness strategy, facilitate mock inspections, and lead preparation and responses for regulatory inspections and audits.

Requirements

• 12+ years of progressive clinical quality assurance experience with a bachelor's degree, or 10+ years of equivalent experience with an advanced or postgraduate degree.
• Extensive knowledge of GCP guidelines, ICH E6(R2), applicable regulations, and company SOPs.
• Demonstrated experience conducting clinical trial audits and inspections.
• Strong leadership, analytical, problem-solving, communication, and cross-functional collaboration skills.
• Ability to mentor CQA staff and contract auditors and contribute to departmental strategy, budgeting, and resource planning.
• Ability to work onsite at least 3 days per week in Jersey City or Millbrae and travel up to 50% domestically and internationally.

Nice to have

• RAC or CQA certification.
• Pharmacovigilance auditing experience.
• Expertise in Veeva systems.

Culture & Benefits

• 401(k) plan with company matching.
• Medical, dental, and vision insurance, with most premiums covered by hirify.global.
• Mental health and wellness benefits.
• Weeklong summer and winter holiday shutdowns, generous paid time off, and holiday policies.
• Enhanced parental leave, life and AD&D insurance, and a subsidized daily lunch program when onsite.