Senior Quality Lead

Genentech • Daly City, CA

7d • $141,000 - $261,800

About The Position

The Senior Quality Lead joins Genentech/Roche’s Quality Assurance Programs team within Pharma Development Quality (PDQ). The role develops and delivers risk-based Quality Assurance strategies, audits, and conclusions for post-approval products, affiliates, and processes, applying the Critical to Quality framework across GCP, GVP, medical device, and computer systems requirements. It requires strong GCP knowledge and accountability for quality assurance aspects of key molecules, including leading or supporting regulatory inspections. Device and CSV experience are preferred but are not the primary requirement.

The role partners with business stakeholders and PDQ domains, independently assesses risk areas and defines quality approaches, manages complex quality issues, and communicates compliance risks and conclusions. It also contributes to PDQ strategy and processes, leads compliance projects, and mentors other Quality Leads. The position is based at the South San Francisco, California campus; onsite presence is preferred, with a remote option possible. Relocation benefits are not available.

Requirements

• Bachelor’s degree or equivalent in a scientific or quality-related field.
• Demonstrated applied knowledge of clinical, pharmacovigilance, or drug safety requirements and regulatory requirements.
• Project management experience with proven leadership, mentoring, and coaching capabilities.
• Demonstrated ability to effectively organize and execute tasks.
• Extensive experience, competency, and a proven track record leading multiple complex audit types across multiple GCP areas.
• Strong GCP knowledge; the role is accountable for quality assurance aspects and leading or supporting inspections of key molecules.

Nice To Haves

• Advanced degree.
• Device or CSV experience.
• Strong digital and data literacy.
• Experience hosting, managing, or supporting regulatory authority inspections.
• Ability to formulate clear business questions answerable with data and use data or visualization tools to generate insights.
• Proven ability to influence and negotiate effective solutions, drive change, and assimilate new compliance information and trends.
• Proven experience working in a global, multicultural, matrixed organization.
• Multilingual skills.

Responsibilities

• Develop and deliver risk-based Quality Assurance strategies and conclusions for assigned molecules using the Critical to Quality framework.
• Partner with business stakeholders and independently define Quality Assurance approaches, assess risk areas, and propose strategy modifications.
• Define the audits needed to deliver the Quality Assurance strategy and lead the development of audit methodology, including use of data analytics.
• Independently perform and lead audits, including preparation, conduct, presentation, timely reporting, and evaluation of actions taken.
• Manage complex quality issues, identify systematic issues from individual findings, and escalate significant issues to PDQ management.
• Draw conclusions on Quality Positions and ensure appropriate action plans are developed to determine the acceptability of evidence of compliance.
• Present observations and associated compliance risks to business stakeholders and Pharma representatives, including discussions with Legal and Regulatory Affairs.
• Contribute to PDQ goals and initiatives, including the execution and delivery of PDQ work and development of PDQ processes.
• Lead and support regulatory authority inspections.
• Mentor and support the development of Quality Leads within the team.
• Contribute to PDQ’s long-term strategic direction, lead departmental or cross-functional compliance projects, and lead development or revision of PDQ processes and procedures, including SOPs and Work Instructions.
• Maintain expert knowledge of GCP/GVP regulations, company policies, and SOPs; assess the impact of new regulations; and act as a trainer and mentor for International and Senior Quality Leads.
• Maintain and influence partnerships with senior business stakeholders and PDQ domains, and facilitate global cross-functional collaboration to meet quality standards.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• The position qualifies for company benefits detailed at the provided link.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior