Principal Quality Systems Specialist
Genentech•San Diego, CA
•Onsite
About The Position
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. This role involves providing quality leadership for the development, implementation, and ongoing 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. The specialist will also support and/or lead relevant strategic initiatives.
Requirements
- Bachelor’s or Post-Graduate degree in Science, Engineering, or a related discipline.
- Minimum of 12 years of relevant quality experience in the pharmaceutical or biotechnology industry
- Demonstrated hands-on experience developing, implementing, and auditing quality and compliance programs under GxP, FDA, and EMA regulations and guidances.
- Excellent influencing-without-authority, negotiation, and collaboration skills when working across global operations, partners, and suppliers.
- High flexibility and a "can-do" mindset to navigate ambiguity, challenge the status quo, and manage complex GxP situations autonomously.
- 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.
Nice To Haves
- Experience in Cell & Gene Therapy
- Experience with Veeva Vault
Responsibilities
- 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
- Support internal and external audits, deviation/CAPA management, complaints investigations
- Promote 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
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- Relocation benefits are not approved for this posting.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
