Principal Quality Compliance and Policy Leader

Genentech•Daly City, CA

6d•$174,700 - $324,500•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in life sciences or a related healthcare discipline.
Minimum of 7–12 years of progressive experience in pharmaceutical drug development (or 6–8 years with a Master’s; 5–7 years with a PhD, JD, or MD), with focused experience in regulatory compliance or clinical quality assurance.
Minimum of 8 years in a GCP-related discipline or clinical quality assurance role, demonstrating expert-level knowledge of GCP/ICH guidelines, global health authority regulations (e.g., FDA, EMA), and clinical trial best practices.
Proven track record of strategic problem-solving, matrix leadership, and leading continuous process improvements in complex, fast-paced clinical environments.
Excellent stakeholder management, executive influence, and ability to distill intricate compliance regulations into clear, actionable clinical strategies.

Nice To Haves

Advanced degree (Master’s, PharmD, PhD, or JD) in a scientific, medical, or regulatory discipline.
Direct prior experience supporting Early Clinical Development (Phase 0–IIa/b) and translational research quality assurance.
Proven leadership experience managing or mentoring quality compliance professionals, working groups, or direct reports.
Hands-on experience hosting and leading Health Authority inspections (e.g., FDA, EMA, PMDA) and authoring formal regulatory responses.
Expertise in developing and scaling QMS architectures, quality metrics, and risk-based quality management (RBQM) platforms.

Responsibilities

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.
Champion a robust culture of quality across early development programs through targeted training and strategic compliance communications.
Manage and lead a team through hiring, strategic direction, oversight, ongoing coaching, regular communication, and performance development.