Senior Manager, Clinical Quality Assurance

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Clinical Quality Assurance based in the United States.

This role provides strategic and hands-on quality oversight across clinical development programs, ensuring compliance with global regulations and Good Clinical Practice (GCP) standards.
You will partner closely with clinical study teams, functional leaders, CROs, and external development partners to address quality and compliance requirements.
The position combines audit leadership, inspection readiness, regulatory guidance, and continuous quality improvement.
You will serve as a trusted advisor on GCP requirements and help identify, assess, and mitigate compliance risks throughout the clinical study lifecycle.
The role offers significant exposure to investigator sites, clinical vendors, internal functions, and health authority inspections.
Success requires strong judgment, communication, collaboration, and the ability to manage multiple priorities in a dynamic clinical development environment.

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.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?


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