Senior Manager, Clinical Quality Assurance

Accountabilities

• Provide GCP compliance oversight and quality guidance to clinical study teams, participating in study management meetings, reviewing study documentation, and advising on GCP-related questions.
• Identify, assess, and escalate serious compliance issues, including potential serious breaches, to appropriate Clinical Quality and Quality leadership.
• Maintain comprehensive knowledge of global GCP regulations, ICH guidelines, internal policies, and procedures affecting clinical study conduct.
• Act as a Clinical Quality Assurance point of contact for designated clinical functional areas and support both study-specific and cross-functional quality initiatives.
• Support the management of study deviations, quality events, and CAPAs within the GCP and pharmacovigilance areas.
• Collaborate with CRO quality counterparts and participate in quality-related meetings and oversight activities.
• Lead or support internal and external GCP audits, including planning, scheduling, agenda development, audit execution, report preparation, response evaluation, CAPA management, and audit closure.
• Conduct audits of investigator sites, clinical vendors, and internal clinical functions across GCP, GCLP, and GPvP activities.
• Maintain accurate audit records and results within an electronic quality management system, preferably Veeva Quality Vault, and identify compliance trends from audit and regulatory observations.
• Communicate audit findings and quality-related information clearly to relevant stakeholders and work with auditees to ensure timely completion of corrective and preventive actions.
• Support partner audits, regulatory inspections, inspection readiness initiatives, and pre-approval inspection preparation in collaboration with clinical, functional, CRO, and external partner teams.
• Contribute to strategic quality and compliance process improvement initiatives across the organization.

Requirements

• Bachelor’s degree in a relevant discipline is required, preferably in biological sciences, life sciences, or a related field.
• At least 6 years of experience in pharmaceutical drug development, with significant experience in Clinical Quality Assurance and/or GCP-related functions.
• Strong knowledge and practical interpretation of ICH guidelines and domestic and international GCP regulations.
• Demonstrated experience leading GCP, GCLP, and GPvP audits of clinical vendors, investigator sites, and internal clinical functions.
• Previous experience managing inspection readiness activities and supporting inspections conducted by the FDA, EMA, and other health authorities.
• Quality Auditor or Quality Manager certification is preferred.
• Strong understanding of clinical quality systems, audit lifecycle management, deviations, CAPAs, and compliance risk management.
• Excellent relationship-building skills, with the ability to collaborate effectively with department leaders, peers, study teams, CROs, and external partners.
• Highly self-motivated and proactive, with the ability to take ownership, work independently, and manage multiple responsibilities in a changing environment.
• Strong organizational skills and the ability to adapt quickly to shifting priorities and tight timelines.
• Excellent customer-service orientation, professionalism, judgment, and communication skills.
• Exceptional written and verbal communication abilities, including confidence in presenting audit findings and compliance matters to diverse stakeholders.
• Ability to work effectively in a primarily office-based environment using standard computer and office equipment and perform occasional physical activities associated with retrieving, handling, and organizing materials.

Benefits

• Annual salary range of $165,000–$180,000 USD, depending on qualifications, experience, skills, internal equity, and market factors.
• Opportunity to participate in stock programs.
• Performance-based bonus opportunity.
• Comprehensive benefits package.
• Supportive environment focused on clinical quality, regulatory compliance, and professional collaboration.
• Position may be based at a designated California location or performed remotely within the United States.