Director, Clinical Quality Assurance (CQA)

• Provide Quality Assurance oversight for multiple global clinical studies, ensuring compliance with international GCP standards and regulatory expectations.
• Develop and implement Clinical Study Quality Plans focused on participant safety, trial integrity, and inspection readiness.
• Partner with study teams by attending governance meetings, advising on quality matters, and supporting proactive risk management practices.
• Identify, escalate, and drive resolution of significant GCP compliance issues with urgency and sound judgment.
• Plan, perform, and oversee audits of clinical investigator sites, vendors, and other high-risk partners.
• Communicate audit outcomes clearly and manage CAPA processes through tracking, review, approval, and effectiveness checks.
• Review critical clinical documents such as protocols, investigator brochures, safety reports, summaries, and regulatory submissions for quality and completeness.
• Support investigation of study quality events, including potential serious breaches, deviations, and corrective actions.
• Strengthen the Clinical Quality Management System through process enhancements, SOP development, training programs, and continuous improvement initiatives.
• Lead inspection readiness activities and support regulatory inspections involving clinical operations and study conduct.
• Collaborate with supply chain, GMP Quality, and Clinical Operations teams regarding clinical supply quality matters.

Requirements:

• Bachelor’s degree in life sciences, science, or related field required; advanced scientific degree preferred.
• 10+ years of experience in regulated environments such as Quality, Regulatory, Pharmacovigilance, or Clinical Development/Operations; or 7+ years with an advanced degree.
• Strong background in Clinical Quality Assurance supporting global clinical trials.
• Minimum 4 years of direct CQA experience including GCP audits and oversight of multinational studies.
• Solid understanding of GCP regulations and quality systems for investigational products.
• Experience supporting trials in international regions, including APAC, is highly valuable.
• Proven ability to assess risks, manage CAPAs, and lead cross-functional problem solving.
• Excellent written and verbal communication skills with strong stakeholder management capabilities.
• Comfortable operating in dynamic biotech environments with changing priorities and limited direction.
• Strong organizational skills, attention to detail, and ability to manage multiple initiatives simultaneously.
• Prior people management experience is beneficial.
• Ability to travel approximately 5% as needed.

Benefits:

• Base salary range of $205,000 - $235,000 USD.
• Competitive compensation package based on experience, location, and qualifications.
• Opportunity to work remotely or within a flexible professional environment, depending on business needs.
• Comprehensive healthcare and wellness benefits.
• Exposure to innovative late-stage biotechnology programs with meaningful patient impact.
• Career development opportunities in a growing and science-driven organization.
• Inclusive workplace committed to equal opportunity and diversity.
• Collaborative culture focused on learning, respect, and innovation.