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.
