Title: Validation Lead– CoreAI
Location: San Francisco, CA
We drive and realise cell and gene therapies by translating scientific progress into life-changing experiences for patients.
❖ Global Reputation for industry-leading contributions
❖ Cell and Gene Therapy powerhouse at Roche
❖ Driver of life-changing treatment for patients
❖ Talent destination and incubator
❖ Partner of choice and Pioneer in a new era in medicine
About the role:
In Pharma Technical Operations (PT), Roche is advancing a cutting-edge pipeline of Cell and Gene Therapies (CGT) to bring transformative treatments to patients. Scaling these complex, individualized modalities from early technical development into commercial manufacturing demands a robust, automated digital ecosystem. As the Validation Lead for CoreAI Lab Instrument Integration, you will direct the Computer Systems Validation (CSV) and Computer Software Assurance (CSA) strategy for integrating analytical and quality control laboratory instruments into the Tetra Data Platform (TDP). You will bridge the gap between fast-paced experimentation in Analytical Development (AD-non GxP) and strict GxP compliance in Quality Control (QC). Working directly with instrument specialists, data engineers, automation architects, and QA SMEs, you will ensure our automated data acquisition pipelines safeguard data integrity, satisfy 21 CFR Part 11 standards, and accelerate release-by-exception for life-saving cell therapies.
Responsibilities:
● Validation Strategy & Governance: Formulate and execute a validation strategy for laboratory instrument integration via the Tetra Data Platform, ensuring alignment with GAMP 5, Roche Quality Management Standards, and global health authority regulations (FDA, EMA, Swissmedic).
● Pipeline & Interface Qualification: Author and execute validation master plans (VMP), user requirements specifications (URS), risk assessments, and qualification protocols (IQ/OQ/PQ) for Tetra Data Hubs, Tetra Agents, cloud connectors, and raw-to-IDS (Intermediate Data Schema) parsing pipelines.
● Data Integrity & Compliance Architecture: Enforce ALCOA+ data integrity principles and 21 CFR Part 11 / EU Annex 11 compliance across all instrument data streams. Qualify automated audit trail capture, electronic signatures, and bidirectional metadata flows between instruments and Level 3 systems (LIMS, ELN, LES).
● Risk-Based Testing & Test Automation: Lead end-to-end verification and boundary testing alongside dedicated testers and QA. Drive the adoption of automated test scripts within CI/CD pipelines to validate data ingestion schemas and reduce manual regression testing.
● Stakeholder & Vendor Alignment: Collaborate closely with Analytical Development scientists, QC lab leads, IT/OT engineers, and cloud platform architects to define scope and acceptance criteria. Partner with vendors (TetraScience, analytical instrument Original Equipment Manufacturers) to review vendor documentation and establish supplier
quality assessments.
● Lifecycle & Change Management: Manage the validation lifecycle through operational changes, patch releases, schema upgrades, and new instrument onboarding, maintaining a continuous state of control and inspection-readiness.
Candidate requirements:
● Analytical Instrument & Platform Knowledge: Experience validating laboratory instrument interfaces (e.g., flow cytometers, automated cell counters, ddPCR, SPR/Biacore, HPLC/UPLC) and modern scientific cloud data platforms (specifically TetraScience / Tetra Data Platform).
● Regulatory & Framework Mastery: Knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and PIC/S data integrity guidance.
● Validation Documentation: Strong track record authoring clear, audit-ready validation deliverables (Traceability Matrices, Risk Assessments, Test Protocols, Validation Summary Reports) in electronic quality tools (e.g., ServiceNow, HP ALM, or Jira).
● Direct experience in Cell and Gene Therapy (CGT) technical operations is a plus
● Familiarity with Roche internal CSV frameworks and Quality Management System processes is a plus.
● Knowledge of pharma and/or cell & gene therapy supply chain processes is a plus.
● Demonstrates ability to perform detail-oriented work with a high degree of accuracy and able to explain complex concepts with clarity and simplicity.
● Demonstrates ability to identify, troubleshoot and resolve issues quickly and effectively.
● Positive attitude and high energy with exceptional cross-group collaboration working with partner teams
● Possess a combination of analytical thinking, hands-on problem-solving, and a customer-service mindset
● Experience in ServiceNow and AWS technologies
● Excellent communication skills - fluent in written and spoken english.
● Language - English / Travel Requirement - 20% (as needed)
