Genentech discovers, develops, manufactures and commercializes treatments for patients with serious and life-threatening medical conditions. Backed by North Carolina Biotechnology Center.
About the role
As the Principal Clinical Quality Compliance and Policy Lead, you will serve as a strategic advisor embedded across Early Clinical Development (ECD) study teams. In this leadership role, you will champion a proactive quality culture, translating complex global regulatory requirements into pragmatic, robust clinical compliance strategies that advance our groundbreaking early-stage clinical trial pipeline. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Drive strategic partnerships across Early Clinical Development (ECD) and global cross-functional stakeholders to align compliance strategy and address high-complexity quality matters
- Provide strategic quality direction , Good Clinical Practice (GCP) compliance expertise, and proactive risk-mitigation frameworks for early clinical study programs
- Lead high-impact global initiatives , working groups, and compliance policy development as a key decision-maker and strategic reviewer
- Oversee Quality Management System (QMS) activities , including deviation management, robust root cause analysis, and strategic Corrective Action/Preventive Action (CAPA) evaluations
- Direct Health Authority inspection readiness initiatives , Standard Operating Procedure (SOP) optimizations, and strategic response frameworks for global regulatory inspections
- Establish Key Quality Indicators (KQIs) and compliance metrics to proactively identify systemic trends, mitigate study risks, and drive continuous organizational improvement
More about this role
Why Genentech
We’re passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while boldly pursuing answers to the world’s most complex health challenges and transforming society.
The Opportunity
As the Principal Clinical Quality Compliance and Policy Lead, you will serve as a strategic advisor embedded across Early Clinical Development (ECD) study teams. In this leadership role, you will champion a proactive quality culture, translating complex global regulatory requirements into pragmatic, robust clinical compliance strategies that advance our groundbreaking early-stage clinical trial pipeline.
- Drive strategic partnerships across Early Clinical Development (ECD) and global cross-functional stakeholders to align compliance strategy and address high-complexity quality matters.
- Provide strategic quality direction , Good Clinical Practice (GCP) compliance expertise, and proactive risk-mitigation frameworks for early clinical study programs.
- Lead high-impact global initiatives , working groups, and compliance policy development as a key decision-maker and...
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