Principal Quality Compliance and Policy Leader

About the role

Genentech is looking for a Principal Clinical Quality Compliance and Policy Lead to act as a strategic advisor embedded across Early Clinical Development (ECD) study teams. The role champions a proactive quality culture, turning complex global regulatory requirements into pragmatic clinical compliance strategies for early-stage clinical trials. It is based in South San Francisco on a hybrid schedule of three days per week on campus.

Key responsibilities

• Drive strategic partnerships across ECD and global cross-functional stakeholders to align compliance strategy and address high-complexity quality matters.
• Provide quality direction, GCP compliance expertise and proactive risk-mitigation frameworks for early clinical study programs.
• Lead 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, root cause analysis and CAPA evaluations.
• Direct Health Authority inspection readiness, SOP optimization and response frameworks for global regulatory inspections.
• Establish Key Quality Indicators (KQIs) and compliance metrics to identify trends and mitigate study risks.
• Champion a quality culture through training and compliance communications.
• Manage and lead a team through hiring, direction, coaching and performance development.

Required profile

• Bachelor's degree in life sciences or a related healthcare discipline.
• 7-12 years of progressive experience in pharmaceutical drug development (6-8 years with a Master's; 5-7 years with a PhD, JD or MD).
• Minimum 8 years in a GCP-related discipline or clinical quality assurance role.
• Proven strategic problem-solving, matrix leadership and stakeholder management.
• Preferred: advanced degree, direct experience in Early Clinical Development (Phase 0-IIa/b) quality assurance, leadership of quality compliance teams, and hands-on experience hosting Health Authority inspections and writing regulatory responses.

Required skills

• Expert knowledge of GCP/ICH guidelines and global health authority regulations (FDA, EMA)
• Quality Management System (QMS) and risk-based quality management (RBQM)
• Good Clinical Practice (GCP) compliance

What we offer

• Expected salary range of $174,700 - $324,500 per year, depending on experience and qualifications; a discretionary annual bonus may be available.
• Hybrid schedule of three days per week on campus.
• No relocation benefits are available for this posting.