About the Role
This role is responsible for building and overseeing a robust quality assurance function, supporting clinical-stage programs, managing regulatory inspections, and ensuring product quality across internal and external operations.
Responsibilities
- Lead the design and implementation of a comprehensive quality management system
- Ensure compliance with FDA, EMA, and other global regulatory standards
- Oversee internal and supplier audits to verify quality adherence
- Manage responses to regulatory agency findings and inspection outcomes
- Develop quality strategies aligned with clinical development timelines
- Lead quality oversight for contract manufacturing and testing organizations
- Establish standard operating procedures for quality processes
- Support regulatory submissions with quality documentation
- Drive continuous improvement in quality systems and practices
- Evaluate and approve critical quality documentation
- Manage product lifecycle quality requirements from development through commercialization
- Ensure proper handling and investigation of deviations and non-conformances
- Oversee change control and corrective action processes
- Lead quality risk assessments across operations
- Train staff on quality policies and regulatory expectations
- Collaborate with cross-functional teams on quality integration
- Monitor key quality performance indicators
- Ensure data integrity within quality systems
- Support facility readiness for regulatory audits
- Maintain up-to-date knowledge of evolving regulations
- Manage vendor qualification and performance from a quality perspective
- Oversee documentation control systems
- Ensure proper validation of quality-critical systems
- Promote a culture of quality and compliance
- Report directly to senior leadership on quality performance
Compensation
Competitive salary and equity package offered based on experience
Work Arrangement
Hybrid work model with flexibility for remote and on-site collaboration
Team
Part of the leadership team driving quality systems within a growing biotechnology organization
Why Join Us
- Opportunity to shape the foundation of a quality function in a science-driven company advancing novel therapeutics
- Work closely with experienced leaders in drug development and biotechnology innovation
Location
- Position based in South San Francisco with hybrid work options
- Access to biotech innovation hub and collaborative research ecosystem
Visa sponsorship available for qualified candidates
