The Principal Quality Systems Specialist is responsible for providing quality oversight and expertise of the pharmaceutical quality systems for the Cell and Gene Therapy team based in San Diego, CA. You will also provide quality leadership of the development, implementation, and on-going management of the quality management system and programs including risk management, change management, planned and unplanned events, training, documentation and records management, and data integrity. Lastly, you will support and/or lead relevant strategic initiatives, as applicable.
The Opportunity
- Coordinate work across systems, functions, and sites to harmonize workflow, clearly identify responsibilities, and optimize cross functional team member participation
- Lead development, review, and revision of SOPs and procedural documents
- Collaborate with subject matter experts to determine training needs and update curricula
- Monitor implementation of systems and assist in execution, performance and effectiveness ensuring compliance to procedures and regulations and identifying areas for improvement
- Create routine and ad hoc Quality Management Review metrics for all Quality Systems
- Provide project and validation oversight related to Quality Systems applications
- Additional responsibilities include supporting internal and external audits, deviation/CAPA management, complaints investigations, all while promoting a culture of compliance throughout the organization through continuous improvement initiatives
- Continue to improve Roche’s overall Quality Management System (QMS) and quality manual, policies, and procedures while keeping them current with emerging and changing regulations, guidance documents, and current industry best practices and expectations.
- Provide timely support for Health Authority interactions and author/review responses to relevant Health Authority information requests
- Perform tasks in a manner consistent with safety policies, quality systems, and cGTP/GMP and Health Authority requirements and guidances
- Contribute to Roche’s strategy for cell and gene therapy industrialization
Who You Are
- Education: Bachelor’s or Post-Graduate degree in Science, Engineering, or a related discipline.
- Industry Experience: Minimum of 12 years of relevant quality experience in the pharmaceutical or biotechnology industry (experience in Cell & Gene Therapy and Veeva Vault preferred).
- Regulatory Expertise: Demonstrated hands-on experience developing, implementing, and auditing quality and compliance programs under GxP, FDA, and EMA regulations and guidances.
- Cross-Functional Leadership: Excellent influencing-without-authority, negotiation, and collaboration skills when working across global operations, partners, and suppliers.
- Problem-Solving & Agility: High flexibility and a "can-do" mindset to navigate ambiguity, challenge the status quo, and manage complex GxP situations autonomously.
- Communication & Culture: Strong written and verbal communication skills with the ability to articulate both strategic vision and tactical execution, paired with high intercultural awareness for global cross-site work.
The expected salary range for this position based on the primary location of California is $114,700-$212,900. 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 in this link.
This is an on-site position.
Relocation benefits are not approved for this posting.
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.
Skills Required
- Bachelor's or postgraduate degree in science, engineering, or a related discipline
- At least 12 years of relevant quality experience in the pharmaceutical or biotechnology industry
- Hands-on experience developing, implementing, and auditing quality and compliance programs under GxP, FDA, and EMA regulations and guidance
- Experience in cell and gene therapy
- Experience with Veeva Vault
- Cross-functional leadership, influencing without authority, negotiation, and collaboration skills
- Ability to manage complex GxP situations autonomously and navigate ambiguity
- Strong written and verbal communication skills
- Intercultural awareness for global cross-site collaboration
Genentech Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Genentech and has not been reviewed or approved by Genentech.
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Healthcare Strength — Health coverage is described as comprehensive across medical, dental, vision, mental health, and prescriptions, supported by HSAs/FSAs and broad wellness resources. On‑site fitness and health centers, mental‑health clinicians, and specialized programs like fully covered preventive cancer screenings and menopause support deepen the offering.
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Retirement Support — Retirement benefits feature a 401(k) with up to a 4% company match plus an additional annual 6% company contribution to eligible pay. Additional financial protections such as life and accident insurance complement salary, bonuses, and stock options.
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Leave & Time Off Breadth — Time away includes about 20 paid vacation days, paid holidays, personal days, and a year‑end shutdown. A paid six‑week sabbatical every six years notably expands long‑term time‑off flexibility.
Genentech Insights
What We Do
Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years. Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal. Making a difference in the lives of millions starts when you make a change in yours.
