GxP Systems Lead - Pharma, Remote & CSV Expert

Ekman Associates, Inc.; Irvine (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

Ekman Associates, Inc. is seeking a GxP Systems Lead SME who is highly hands-on and execution-focused to own and drive deliverables across Quality, Clinical, Regulatory and IT in a remote setting.

You will manage a portfolio of GxP systems (including Veeva Vault) in regulated environments, ensure robust CSV validation, and maintain audit readiness while aligning with global GxP regulations and GAMP 5. This senior role emphasizes ownership, cross-functional collaboration, and rapid, compliant

Qualifications

• Experience managing a portfolio of GxP systems incl. Veeva Vault in regulated environments.
• Expertise in Computer System Validation (CSV) and regulatory validation.
• Knowledge of FDA/EMA/ICH GxP regulations and GAMP 5 principles.

Responsibilities

• Hands-on support for GxP systems including Veeva Vault and non-Veeva platforms in regulated environments.
• Own CSV validation lifecycle: URS, FS, IQ/OQ/PQ, TM from initiation to closure.
• Apply global GxP regulations and maintain audit/inspection readiness.
• Lead project management: planning, execution, risk management, delivery of implementations.
• Collaborate with Quality, Clinical, Regulatory and IT to gather requirements and drive decisions.
• Oversee system configurations, releases, integrations, and change controls.
• Ensure data integrity (ALCOA+) and manage vendors for GxP apps.
• Conduct gap assessments against SOPs/regulatory requirements and remediation.

Skills

GxP systems portfolio

Veeva Vault (RIM/Clinical)

CSV validation

Education

Bachelor's degree in IT/Engineering or related

Tools

SNOW ITSM

Job description

Ekman Associates, Inc. is seeking a GxP Systems Lead SME who is highly hands-on and execution-focused to own and drive deliverables across Quality, Clinical, Regulatory and IT in a remote setting.

You will manage a portfolio of GxP systems (including Veeva Vault) in regulated environments, ensure robust CSV validation, and maintain audit readiness while aligning with global GxP regulations and GAMP 5. This senior role emphasizes ownership, cross-functional collaboration, and rapid, compliant