Compliance Lead (SAP S/4HANA)

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

Senior Technical Lead / Compliance Lead (SAP S/4HANA)
Location: West Point, Pennsylvania | C2C | Hybrid (3 days onsite, 2 days remote)
Pay Rate: $75/hr
Industry: SAP S/4HANA / GxP Compliance / Pharmaceutical IT
End Date: 26-Nov-2026

Job Description
We are seeking a Senior Technical Lead / Compliance Lead with strong expertise in SAP S/4HANA and GxP-regulated environments. The ideal candidate will be responsible for providing compliance oversight, ensuring regulatory alignment, and guiding quality practices across SAP programs. This role requires hands‑on experience with S/4HANA or ECC GxP functionality, validation strategies, data migration oversight, and SDLC governance using CSA principles. The position will collaborate closely with cross‑functional teams, lead quality reviews, drive CAPA activities, and ensure audit readiness across systems and processes.

Responsibilities

• Provide end-to-end quality oversight for GxP computerized systems, including audit preparation and remediation.
• Lead and validate SAP S/4HANA/ECC GxP functionality, including data migration, interface qualification, and report validation.
• Define and implement risk-based validation strategies using Computer System Assurance (CSA) frameworks.
• Drive functional and regression testing strategy, ensuring quality requirements are embedded from project inception.
• Conduct root cause analysis for IT system incidents, develop CAPAs, and ensure timely closure and verification.
• Serve as SME for Data Integrity, overseeing remediation efforts and ensuring compliance controls.
• Review and approve SDLC deliverables, system change requests, and validation documentation.
• Guide teams in authoring SOPs, WIs, and compliant documentation practices.
• Lead cross-functional meetings to resolve compliance issues and provide governance for system quality.
• Collaborate with stakeholders to ensure system compliance aligns with business and regulatory expectations.

Required 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.
• Experience with data migration validation, interface qualification, test planning, and risk-based approaches.
• Strong knowledge of Data Integrity principles and regulatory guidelines.
• Ability to lead CAPA, audits, investigations, and documentation governance.
• Excellent communication, leadership, and stakeholder management skills.