Senior Clinical Quality Compliance and Policy Leader

Genentech; San Francisco (CA); Hybrid; USD 141,000 - 262,000; Full time

Job summary

Genentech in South San Francisco is seeking a Quality Partner for Early Clinical Development to champion a proactive, risk-based quality culture and to serve as the primary GCP quality advisor to early-stage study teams and external partners.

You will embed quality by design across cutting-edge programs, resolving compliance challenges before they impact timelines or regulatory integrity. This role drives CAPA and root cause analyses across the organization.

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree welcomed.
• 5–8 years in pharmaceutical drug development with 6+ years in GCP/QA.
• Strong knowledge of GCP, ICH guidelines, and global regulatory frameworks.

Responsibilities

• Develop strategic partnerships across ECD and external partners to improve compliance.
• Provide expert GCP guidance and proactive risk mitigation for trials.
• Lead QMS activities and document management as needed.
• Deliver training to multidisciplinary teams on compliance.
• Lead root cause analyses and CAPA plan development.
• Collaborate with cross-functional teams to align regulatory requirements.

Skills

GCP knowledge

Regulatory knowledge

Root cause analysis

CAPA development

Cross-functional collaboration

Stakeholder management

Education

Bachelor's degree in life science

Advanced degree welcomed (MS/PhD/JD/MD)

Job description

The Position

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 a Quality Partner within Early Clinical Development (ECD) Quality, you will champion a proactive, risk-based quality culture that enables innovative science to move safely and efficiently to patients. You will serve as the primary Good Clinical Practice (GCP) quality advisor and strategic partner to early-stage clinical trial study teams and external partners. In this role, you will embed quality by design across cutting-edge Early Development clinical programs, resolving complex compliance challenges before they impact study timelines or regulatory integrity.

• Develop strategic partnerships with cross-functional teams in Early Clinical Development (ECD) and external vendor partners to advance compliance solutions and enable transparent issue resolution.
• Provide expert GCP quality guidance, direction, and proactive risk-mitigation strategies to support early clinical trial conduct.
• Support and participate in intradepartmental, global, and cross-functional initiatives, working groups, and project teams as a key decision-maker or lead reviewer.
• Support or lead Quality Management System (QMS) activities, including controlled document management, strategic reviews and process alignment.
• Embed quality principles throughout the organization by delivering impactful compliance communications and targeted training to multidisciplinary teams.
• Collaborate on quality compliance checks and desktop assessments to evaluate clinical trial oversight and data integrity.
• Guide clinical study teams through root cause analysis, deviation management, and Corrective Action/Preventative Action (CAPA) plan development.

Who you are

• You bring a Bachelor’s degree in a life science, healthcare, or related discipline (advanced degree such as MS, PhD, JD, or MD welcomed).
• You possess 5–8 years of experience in pharmaceutical drug development (or 4–6 years with a Master’s; 3–5 years with a PhD, JD, or MD), with a minimum of 6 years dedicated to a GCP-related discipline or Quality Assurance role.
• You hold comprehensive working knowledge of Good Clinical Practice (GCP), ICH guidelines, and global regulatory frameworks and how to apply them to clinical trial conduct.
• You bring proven analytical and problem‑solving skills, with a track record of identifying compliance risks, facilitating root cause analyses, and architecting practical CAPA solutions.
• You excel at cross‑functional collaboration and stakeholder management, with the ability to translate regulatory requirements into clear, actionable guidance while managing priorities independently.

Preferred

• Direct experience supporting Early Clinical Development (ECD) or first-in-human (Phase I/Ib) clinical trials.
• Hands‑on experience with Health Authority inspection preparedness, sponsor/site inspection hosting, and response strategy development (e.g., FDA, EMA).
• Demonstrated experience with external vendor/CRO quality oversight, audits, and desktop assessments.
• Background in supporting Quality Management System (QMS) processes and procedural documents.
• Professional certifications in clinical research or quality assurance (e.g., RQAP‑GCP, RAC, SQA).

Location

• This role is based in South San Francisco and offers a hybrid schedule working 3 day per week on campus
• No relocation benefits are available for this posting

The expected salary range for this position based on the primary location of CA is $141,100 - $262,100 Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.