Senior GxP CSV Compliance Strategist

Insight Global

Spring House (PA)

Hybrid

USD 103,000 - 131,000

Full time

11 days ago

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Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

HSA, FSA, DCFSA options

401k with employer matching

Paid sick leave / PTO as provided by/法

Job summary

Insight Global is seeking a Senior Computer Systems Compliance Specialist for a hybrid role in Spring House, PA. This 3-month extending contract offers a competitive hourly rate and comprehensive benefits starting day one.

The project focuses on GxP computer systems, CSV, data integrity, and regulatory compliance, with cross-functional collaboration across North America and Europe. Responsibilities include independent compliance health checks, risk-based remediation planning, and concise

Qualifications

8+ years in pharmaceutical GxP, CSV, or quality compliance.
Independent reviews of GxP computerized systems and validation docs.
Ability to identify risks, gaps, and remediation opportunities.

Responsibilities

Compliance Assessments & System Reviews (60%): conduct independent reviews of GxP computerized systems and supporting validation documentation.
Assess system compliance against CSV requirements and GxP regulations.
Evaluate intended use, classification, validation strategy, and ongoing compliance.
Review requirements traceability, testing evidence, change control, and lifecycle docs.
Assess electronic records and electronic signature controls; evaluate data integrity controls.
Review supplier management controls, periodic reviews, and lifecycle processes.
Determine fitness-for-use of systems for regulated processes.
Stakeholder Engagement (20%): conduct interviews with system owners, validate observations, and maintain strong relationships.
Reporting & Recommendations (20%): document observations, risks, and remediation opportunities; deliver executive-level reports.