Lead, Computerized Systems Validation - Canada
Core
Senior individual contributor leading complex, high-risk computerized system validation (CSV) initiatives for GxP systems across the lifecycle, ensuring data integrity and regulatory compliance. (via careerplan.io/jobs/15-003-E0-37A-lead-computerized-systems-validation-canada-at-indero)
Role type
Senior IC Computerized Systems Validation Lead
Builds
Validated GxP computerized systems, upgrades, and retirements for a dermatology CRO
Domain
Life Sciences / Regulatory Compliance (GxP)
Required skills
GxP regulations, risk-based validation strategy, data integrity, vendor qualification, audit support, change control, CAPA, system retirement, cloud/SaaS, electronic records and signatures
Preferred skills
emerging technology, artificial intelligence, connected devices, automation
Technologies
Cloud services, SaaS, connected devices, automation, AI
Responsibilities
Lead validation workstreams for new GxP systems, upgrades, and retirements; Develop and approve validation deliverables (plans, test scripts, traceability matrices); Provide technical oversight of validation execution and defect resolution; Mentor CSV Analysts and provide functional direction; Support internal, vendor, and regulatory audits; Maintain knowledge of evolving technologies and regulations.
Seniority
Senior, hands-on IC with mentorship