Hiring: Principal Quality Lead Company: Genentech Location: South San Francisco, CA Job Posted Time: 2026-09-16 15:45:12 Employment Type: On-site Target Skills & Keywords : GCP, Project Management, Quality Assurance About the job Experience: •10 years in pharmaceutical industry and/or nonclinical/clinical research/PV experience •8 years in GCP/PV/CS related discipline / Quality Assurance role (auditing) •Minimum 10 years in pharmaceutical industry and/or nonclinical/clinical research/PV experience •Minimum 8 years in GCP/PV/CS related discipline / Quality Assurance role (auditing) Required Skills: •The Quality Lead will generate Quality strategies, evidence and actionable data through the conduct of audits and other quality activities to assess the Quality status and be able to support the demonstration of effective implementation of Quality Assurance to stakeholders and Health Authorities. •Design and Implement Quality Strategies: Establish strong partnerships with business stakeholders and independently define the Quality Assurance approach, assessing specific risk areas and proposing strategy modifications. •Define Audits and Methodology: Define the audits required to deliver the Quality Assurance strategy and lead the development of methodology, including the use of data analytics. •Perform and Lead Audits: Independently perform and lead audits, managing preparation, conduct, presentation, timely reporting of outcomes, and evaluation of actions taken. •Issue Management: Independently manage 'for cause,' critical, and/or complex quality issues, group individual findings into systematic issues for process improvement, and escalate significant issues to PDQ management. •Quality Conclusion Drawing: Independently draw conclusions on the Quality Positions and ensure appropriate action plans are developed to determine acceptability of evidence of compliance. •Stakeholder Communication: Lead the presentation of observations and associated compliance risks to business stakeholders and Pharma representatives, including discussions with Legal and Regulatory Affairs regarding compliance issues. •Health Authority Inspections: Lead inspection preparation and management of Health Authority inspections, including providing inspection training to staff and presenting Quality Strategies and conclusions. Qualifications: •Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience; Advanced degree in referenced fields preferred •Demonstrated applied knowledge of clinical / pharmacovigilance / drug safety and regulatory requirements, as well as analytical, organizational and planning skills •Project management experience with proven leadership, mentoring and coaching; Demonstrated ability to effectively organize and execute tasks •High degree of experience, competency, and proven track record leading multiple complex audit types in multiple GxP/CSV areas; Experience supporting regulatory authority inspections; Strong digital and data literacy •Demonstrated capacity to formulate clear business questions that can be answered with data and in utilizing data and visualisation tools to generate insights •Proven ability to influence and negotiate effective solutions within PDQ, PD, and/or industry through leading change and driving for results; Strong understanding of PDQ business and functional group operations; Proven ability to assimilate new and emerging compliance information or trends and translate into impact for PDQ •Proven record of working in a global, multicultural matrixed organization (multi-lingual skills desirable) •Demonstrated excellent analytical, strategic- thinking, and problem-solving skills with a proven ability to understand business impact •Please note this role is based at our South San Francisco, CA campus. Onsite presence is required. •Relocation benefits are not available for this job posting. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!