qms jobs in San Diego

Principal System Architect responsible for designing and maintaining a complex enterprise automation ecosystem spanning RPA, Machine Learning, and GenAI across multiple business units. The role requires architecting data pipelines integrating diverse systems (SAP, ERP, QMS, PLM tools like Windchill), leading automated workflow solutions (ECPs, QA defect prediction, EVMS reporting), and ensuring end-to-end cybersecurity compliance with DoD standards, CMMC, and Zero Trust architectures.…See more This is a senior technical leadership position requiring 14+ years of IT system architecture experience, deep expertise in intelligent automation and ML/AI, and the ability to mentor teams and present technical strategies to executive stakeholders.

Sr. Specialist overseeing quality assurance systems, records management, and compliance in a pharmaceutical/biotech GxP-regulated environment.…See more Responsibilities include managing electronic quality systems, processing controlled documents and SOPs, supporting inspections and audits, analyzing quality metrics and dashboards, leading process improvement initiatives, and mentoring junior staff. Requires a bachelor's degree with 4+ years of pharma/biotech QA experience (or master's with 2+), strong knowledge of FDA/ICH/GMP/GLP/GCP regulations, proficiency with QMS and LMS platforms, and demonstrated leadership and analytical capabilities.

Systems Engineer responsible for translating market and user needs into clear requirements across biology, hardware, and software subsystems at an early-stage cell-therapy manufacturing startup. Owns requirements management, interface control documentation, and system block diagrams to keep multiple engineering teams aligned during prototype development.…See more Leads verification, validation, and risk analysis planning; supports design reviews and regulatory compliance through design history file maintenance. Expects hands-on involvement in prototype assembly, testing, and cross-disciplinary problem-solving in a research-to-product transition environment.