Job description
Executive Director, Global Clinical Quality
Location: Bay Area, CA (Hybrid or Remote with periodic onsite presence)
Company Overview
A publicly traded, clinical-stage biotechnology company is advancing a differentiated pipeline of orally available small molecule therapies targeting chronic diseases with significant unmet medical need. The organization leverages advanced computational and structure-based drug discovery technologies and operates across multiple global innovation hubs.
The company is led by experienced drug development executives and supported by leading global life sciences investors. The pipeline spans multiple therapeutic areas including cardiometabolic and pulmonary diseases, with several programs in clinical development.
Position Summary
The Executive Director, Global Clinical Quality provides strategic leadership and global oversight of GxP quality systems supporting clinical development and pharmacovigilance activities. This role is responsible for establishing and scaling phase-appropriate quality frameworks to support a growing clinical pipeline while ensuring compliance with global regulatory requirements.
This leader will partner cross-functionally across Clinical Development, Regulatory Affairs, Safety, Technical Operations, and external partners to drive a proactive, risk-based quality culture. The role also provides enterprise-level oversight across multiple clinical programs aligned with corporate and regulatory objectives.
Key Responsibilities
Global Clinical Quality Strategy & Governance
Qualifications
Education
Additional Information
Location: Bay Area, CA (Hybrid or Remote with periodic onsite presence)
A publicly traded, clinical-stage biotechnology company is advancing a differentiated pipeline of orally available small molecule therapies targeting chronic diseases with significant unmet medical need. The organization leverages advanced computational and structure-based drug discovery technologies and operates across multiple global innovation hubs.
The company is led by experienced drug development executives and supported by leading global life sciences investors. The pipeline spans multiple therapeutic areas including cardiometabolic and pulmonary diseases, with several programs in clinical development.
The Executive Director, Global Clinical Quality provides strategic leadership and global oversight of GxP quality systems supporting clinical development and pharmacovigilance activities. This role is responsible for establishing and scaling phase-appropriate quality frameworks to support a growing clinical pipeline while ensuring compliance with global regulatory requirements.
This leader will partner cross-functionally across Clinical Development, Regulatory Affairs, Safety, Technical Operations, and external partners to drive a proactive, risk-based quality culture. The role also provides enterprise-level oversight across multiple clinical programs aligned with corporate and regulatory objectives.
Global Clinical Quality Strategy & Governance
- Define and execute global GCP quality strategy aligned with development stage, pipeline expansion, and corporate growth objectives
- Establish and continuously improve global clinical QMS infrastructure, ensuring scalability across regions and programs
- Lead development and lifecycle management of global GCP policies, SOPs, and training frameworks
- Lead global inspection readiness strategy and execution
- Serve as primary Quality SME during regulatory inspections and partner audits
- Provide strategic support for regulatory submissions and agency interactions
- Provide embedded Quality leadership across clinical study teams
- Oversee global vendor qualification, audit strategy, and performance monitoring
- Ensure risk-based oversight across CROs, clinical sites, and service providers
- Own global GCP audit strategy including investigator sites, vendors, and internal systems
- Lead risk identification, trend analysis, and proactive mitigation strategies
- Oversee quality issue management, CAPA strategy, and effectiveness monitoring
- Drive Quality engagement early in development to influence program design and execution
- Partner with Clinical Operations, Clinical Science, Regulatory, and Safety to optimize compliant and efficient processes
- Lead cross-functional quality governance forums and management review processes
- Ensure compliance with global data integrity expectations and electronic systems regulations
- Maintain forward-looking knowledge of regulatory expectations, inspection trends, and industry best practices
Education
- Advanced degree preferred in life sciences, pharmacy, engineering, or related discipline
- 15+ years in pharmaceutical / biotechnology quality functions with deep clinical quality leadership experience
- Extensive experience leading GCP Quality strategy within global clinical-stage organizations
- Demonstrated success supporting global regulatory inspections and partner diligence activities
- Strong experience operating in outsourced development models and managing global vendor networks
- Deep working knowledge of global regulatory frameworks including FDA, EMA, MHRA, PMDA, and ICH
- Enterprise-level strategic thinking and execution
- Strong cross-functional influence and executive presence
- Proven ability to build and scale quality organizations in growth-stage environments
- Strong financial, resource, and program prioritization capabilities
- Expert knowledge of GCP, GLP, ICH guidelines, and global regulatory expectations
- Strong background in data integrity and electronic systems compliance (e.g., Part 11)
- Auditor certification or quality certifications preferred
- Ability to travel domestically and internationally (~10–30%)
- Hybrid or remote structure with periodic onsite collaboration expected