GxP Validation Lead for SAP S/4HANA

The Remas Company; La Verne (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

The Remas Company seeks a Project Manager with extensive Pharma/Biotech/Life Sciences or Medical Device/Healthcare manufacturing experience to drive GxP compliance for SAP S/4 HANA and oversee CSV in a regulated environment.

You will lead validation activities, develop risk-based plans, review requirements, and ensure documentation meets 21 CFR Part 11 and GxP standards across time zones.

Qualifications

• 8+ years validating Computer Systems in Life Sciences.
• 3+ years managing large global SAP validation projects.
• Strong understanding of GxP, FDA and EMEA guidelines including 21 CFR Part 11.
• Proven ability to lead validation engineers across time zones.
• Excellent communication and attention to detail.

Responsibilities

• Lead and perform activities to create and maintain GxP quality environment for SAP S/4 HANA.
• Monitor Computer System Validation (CSV) and ensure GxP and 21 CFR Part 11 compliance.
• Manage validation of SAP S/4 HANA system.
• Develop validation plans and risk assessments; CQ, DQ, IQ, OQ, PQ protocols.
• Review test scripts and lead protocol executions; track defects.
• Maintain traceability matrix and qualification reports.
• Participate in CAPA and quality metrics; report status.
• Lead validation engineers across different time zones.

Skills

Communication skills

GxP regulations

CSV in Life Sciences

SAP validation

Project leadership

GAMP-5

FDA/EMEA guidelines

Job description

The Remas Company seeks a Project Manager with extensive Pharma/Biotech/Life Sciences or Medical Device/Healthcare manufacturing experience to drive GxP compliance for SAP S/4 HANA and oversee CSV in a regulated environment.

You will lead validation activities, develop risk-based plans, review requirements, and ensure documentation meets 21 CFR Part 11 and GxP standards across time zones.