Executive Director, GxP Quality and Compliance
$265,000–$331,000 year
HybridRedwood City, California, United States
Job Summary
Develop and execute the organization's global GxP compliance strategy, ensuring alignment with corporate objectives and global regulatory requirements. Provide executive leadership for the Quality Compliance function, fostering a culture of quality, integrity, and continuous improvement across the organization. Serve as the executive lead for regulatory inspections, health authority interactions, and inspection readiness activities, while directing the strategy and governance of the Quality Management System. Lead enterprise compliance risk management by proactively identifying, assessing, and mitigating regulatory risks, and partner with PDM, QA, Regulatory Affairs, and Clinical Development to ensure consistent GxP compliance. Establish and communicate quality metrics, dashboards, and KPIs to executive leadership, and champion operational excellence initiatives that strengthen inspection readiness and organizational performance. This role advises senior leadership on global compliance policy and strategy within a late-stage clinical oncology company developing novel targeted therapies for RAS-addicted cancers, reporting to the Vice President, Global Quality.
Required Qualifications
- Advanced degree in life sciences, pharmacy, chemistry, or a related scientific discipline (PhD, MS, or equivalent preferred)
- 15+ years of progressive experience in GxP Quality and Compliance within the pharmaceutical, biotechnology, medical device, or related life sciences industry with extensive knowledge of FDA regulations, ICH Guidelines, EU GMP, and global GxP requirements
- 8+ years of executive or senior leadership experience leading global quality and compliance organizations
- Demonstrated success leading regulatory inspections and maintaining inspection readiness for FDA and international regulatory agencies
- Excellent leadership, communication, strategic planning, cross-functional collaboration and people skills, with the ability to influence stakeholders at all levels
- This role may require occasional travel (up to 15%) for audits, inspections, and meetings
- Flexibility to work in a fast-paced, dynamic environment with evolving priorities
Desired Qualifications
- Experience leading global GxP compliance programs across both clinical development and commercial product environments, including inspection readiness, launch readiness, and post-approval compliance oversight
- Demonstrated success building and scaling enterprise compliance governance in a rapidly growing, highly outsourced biotechnology or oncology-focused organization
- Experience advising executive leadership on global compliance risks, regulatory inspection strategy, quality system maturity, and enterprise-level remediation priorities
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.