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In Genentech Research and Development (gRED), we take immense pride in fostering a culture that thrives on collaboration, innovation, and a shared commitment to improving patients' lives. We are seeking a strategic and experienced leader to head our Quality Systems and Compliance related Learning Solutions Group. This individual should demonstrate strategic agility, exert strong influence across the organization, and apply their expertise to promote quality and compliance principles in support of the Development Sciences (DevSci) and Translational Medicine functions. The successful candidate will devise and employ both strategic and practical business solutions for quality and compliance systems, training systems, and records management/archives.

The Opportunity

As a valuable member on the Development Science team you will be:

• Providing Strategic Oversight: Guide the Development Sciences Quality Systems and Learning Solutions group (direct reports), driving forward-thinking strategies and ensuring anticipated needs are met in areas such as compliance (e.g. GLP, GCP, Privacy Law), training and archives/records management.

• Participating in Cross-functional Collaboration: Partner with key stakeholders like Quality Assurance (PDQ), Early Clinical Development Quality Organization, gRED Business Operations, and the Roche Privacy Office to assess and implement relevant quality and compliance processes, as appropriate.

• Managing Quality Systems: Oversee and manage the Quality Management systems to support Compliance within the organization:

  • Ensuring a controlled document management system is in place

  • Leading an internal Compliance Working group with representatives from DevSci functions, Translational Medicine and Quality Assurance. Charter for the team includes: inspection preparedness, review and risk assessments of processes (as needed), monitoring current compliance trends and/or needs, utilize the team to educate or implement quality systems. Provide updates to Senior Management as appropriate.

  • Sponsoring the Development Science's /Translational Medicine training team. Ensure that each group has necessary compliance related and functional based training for new hires and all employees, including a periodic review of the training matrices. Consider programs to increase training engagement and compliance. Review and set training strategies, as appropriate.

• Partnering with the PDQ Quality Assurance Unit on Health Authority Inspections

  • Guidance on strategy and responses, as appropriate

  • Direct involvement for GLP inspections and others as appropriate (e.g. provide requested documents etc)

  • Notify organization of audits and inspections

• Hosting/Participating in internal audits

• Providing quality guidance, leadership, direction on quality and compliance topics (e.g. CAPA responses) to members of DevSci and Translational Medicine.

• Representing the function on the Knowledge Management/Records Management team. Implement new processes as needed.

Who you are

• A Bachelor's degree (preferably in Life Science) and a minimum of 8-10 years' relevant experience in the pharmaceutical or biopharmaceutical industry.

• Extensive knowledge of GLP/GCPs or equivalent regulation; Proven experience in leading successful compliance/quality organization function.Demonstrating ability to guide implementation and review of Quality standards.

• Proven experience in driving continuous improvement and/or productivity programs.Strategic planning, prioritization and managing high level initiatives and projects.

• Strong problem-solving skills with /organizational- and prioritization skills with the ability to manage multiple projects of varying complexity.

• Experience in developing and managing a team; Proven experience in stakeholder management, influencing change, customer focused approach, effective teamwork and collaboration skills.

Relocation benefits are available for this job posting.

The expected salary range for this position based on the primary location of California is $177,200-$329,000. 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.

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Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.