Principal Quality Compliance and Policy Leader

Roche; South San Francisco (CA); Hybride; USD 175 000 - 325 000; Plein temps

Résumé du poste

Genentech seeks a Principal Clinical Quality Compliance and Policy Lead to partner with Early Clinical Development teams. You will translate global regulatory requirements into pragmatic compliance strategies that strengthen our early-stage trial programs.

You will drive strategic partnerships, provide expert GCP direction, lead global initiatives, and oversee QMS activities with CAPA and deviation management. Hybrid on-site work in South San Francisco.

Qualifications

• Bachelor's degree in life sciences or related field.
• 8+ years in GCP/ICH and regulatory / clinical quality assurance.
• Experience leading cross-functional quality initiatives.
• Ability to translate regulatory requirements into practical strategies.

Responsabilités

• Drive strategic partnerships across ECD and global stakeholders.
• Provide strategic quality direction and proactive risk mitigation.
• Lead global initiatives, working groups, and policy development.
• Oversee QMS activities including deviation management and CAPA.
• Direct Health Authority inspection readiness initiatives and SOP optimizations.
• Establish KQIs and compliance metrics to identify trends.
• Champion a robust culture of quality across early programs.
• Manage and lead a team with coaching and performance development.

Connaissances

Strategic leadership

GCP / ICH knowledge

Regulatory compliance

Stakeholder management

Influential communication

Formation

Bachelor's degree in life sciences

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

Description du poste

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 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.

Who you are

• Education & Foundation: You bring a Bachelor’s degree in life sciences or a related healthcare discipline.
• Industry Experience: You bring a 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.
• GCP & Regulatory Mastery: You possess a 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.
• Strategic Problem Solver & Matrix Leader: You have a proven track record of strategic problem-solving, matrix leadership, and leading continuous process improvements in complex, fast-paced clinical environments.
• Influential Communicator: You excel at stakeholder management, executive influence, and distilling intricate compliance regulations into clear, actionable clinical strategies.

Preferred

• 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.

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 $174,700 - $324,500 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.