Senior Clinical Quality Compliance and Policy Leader

About the role

Genentech is hiring a Quality Partner within Early Clinical Development (ECD) Quality, based in South San Francisco on a hybrid schedule of three days per week on campus. As the primary Good Clinical Practice (GCP) quality advisor, you will champion a proactive, risk-based quality culture and embed quality by design across early-stage clinical programs, resolving complex compliance issues before they affect study timelines or regulatory integrity.

Key responsibilities

• Develop strategic partnerships with ECD teams and external vendors to advance compliance solutions and resolve issues transparently.
• Provide expert GCP guidance, direction and proactive risk-mitigation strategies for early clinical trials.
• Support or lead Quality Management System (QMS) activities, including controlled document management, strategic reviews and process alignment.
• Deliver compliance communications and targeted training to multidisciplinary teams.
• Collaborate on quality compliance checks and desktop assessments of clinical trial oversight and data integrity.
• Guide study teams through root cause analysis, deviation management and CAPA plan development.

Required profile

• Bachelor's degree in a life science, healthcare or related discipline (advanced degrees such as MS, PhD, JD or MD welcomed).
• 5-8 years in pharmaceutical drug development (4-6 years with a Master's; 3-5 years with a PhD, JD or MD), with at least 6 years in a GCP-related discipline or Quality Assurance role.
• Preferred: direct experience with ECD or first-in-human (Phase I/Ib) trials, hands-on inspection preparedness and response strategy work, vendor/CRO oversight and audits, QMS background, and professional certifications such as RQAP-GCP, RAC or SQA.

Required skills

• Working knowledge of Good Clinical Practice (GCP), ICH guidelines and global regulatory frameworks applied to clinical trials.
• Analytical and problem-solving skills, including identifying compliance risks, root cause analysis and CAPA solutions.
• Cross-functional collaboration, stakeholder management and independent prioritization.

What we offer

• Expected salary range of $141,100 - $262,100 annually, depending on experience, qualifications and location; a discretionary annual bonus may be available.
• Hybrid schedule of three days per week on campus.
• No relocation benefits are available for this posting.