Senior Quality Lead

Roche • South San Francisco, 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. Strategies use the Critical to Quality framework and address applicable GCP, GVP, medical-device, and computer-systems requirements. Strong GCP knowledge is essential; CSV and device experience are preferred but are not the primary requirements.

The role partners with business stakeholders and PDQ domains to assess quality risks, plan and lead audits, manage complex quality issues, evaluate compliance evidence, communicate findings and risks, and lead or support regulatory authority inspections. It also contributes to PDQ strategy and initiatives, develops and revises processes and procedures, and mentors 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 unavailable.

Requirements

• Bachelor’s degree or equivalent in a scientific or quality-related field.
• Demonstrated applied knowledge of clinical, pharmacovigilance, or drug-safety and regulatory requirements.
• Project management experience, with proven leadership, mentoring, and coaching skills.
• Demonstrated ability to organize and execute tasks effectively.
• Extensive experience, competency, and a proven track record leading multiple complex audit types across multiple GCP areas.
• Strong GCP knowledge.
• Ability to lead and support regulatory authority inspections.

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 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 are desirable.

Responsibilities

• Develop and deliver risk-based Quality Assurance strategies and conclusions for assigned molecules using the Critical to Quality framework.
• Partner with business stakeholders, assess specific risk areas, and independently define or modify the Quality Assurance approach.
• Determine required audits and lead their methodology, including use of data analytics; independently perform and lead audits from preparation through conduct, presentation, reporting, and evaluation of actions taken.
• Independently manage complex quality issues, group findings into systematic issues for process improvement, and escalate significant issues to PDQ management.
• Draw conclusions on Quality Positions and ensure action plans determine the acceptability of compliance evidence.
• Present observations and associated compliance risks to business stakeholders and Pharma representatives, including discussions with Legal and Regulatory Affairs.
• Contribute to PDQ goals, initiatives, work delivery, and development of PDQ processes.
• Lead and support regulatory authority inspections.
• Mentor and support the development of Quality Leads.
• 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, facilitating global cross-functional collaboration to meet quality standards.

Benefits

• A discretionary annual bonus may be available based on individual and company performance.
• Employee benefits are referenced through a link in the posting, but specific benefits are not listed.

What This Job Offers

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