Senior SAP S/4HANA Compliance Lead – Hybrid & GxP

Simarn, Inc.; Pennsylvania; Hybrid; USD 103,320; Full time

Job summary

A leading pharmaceutical compliance firm is seeking a Senior Technical Lead / Compliance Lead in West Point, Pennsylvania. This role demands expertise in SAP S/4HANA and GxP-regulated environments, providing compliance oversight and guiding quality practices across SAP programs. Candidates should have strong experience with SDLC governance, risk-based validation strategies, and a deep understanding of regulatory requirements. The position offers a pay rate of $75/hr and a hybrid work model, requiring 3 days onsite and 2 days remote.

Qualifications

• Strong experience as a Compliance Lead in SAP S/4HANA or ECC GxP environments.
• Deep understanding of GxP, CSV/CSA, SDLC, and regulatory expectations for pharma/biotech systems.
• Ability to lead CAPA, audits, investigations, and documentation governance.

Responsibilities

• Provide end-to-end quality oversight for GxP computerized systems, including audit preparation.
• Lead and validate SAP S/4HANA/ECC GxP functionality.
• Define and implement risk-based validation strategies using CSA frameworks.
• Drive functional and regression testing strategy, ensuring quality requirements.
• Conduct root cause analysis for IT system incidents and develop CAPAs.

Skills

Compliance oversight

SAP S/4HANA expertise

Data Integrity principles

Regulatory compliance

Stakeholder management

Job description

A leading pharmaceutical compliance firm is seeking a Senior Technical Lead / Compliance Lead in West Point, Pennsylvania. This role demands expertise in SAP S/4HANA and GxP-regulated environments, providing compliance oversight and guiding quality practices across SAP programs. Candidates should have strong experience with SDLC governance, risk-based validation strategies, and a deep understanding of regulatory requirements. The position offers a pay rate of $75/hr and a hybrid work model, requiring 3 days onsite and 2 days remote.