GxP Compliance & Validation Planning Consultant

Founded in 1999 in Vienna, the Qualysoft Group is a manufacturer-independent IT consulting and services company, which successfully provides support for its international customers with the aim of boosting their competitiveness and economic efficiency through innovative IT solutions.

Its focus is on financial services providers, telecommunications companies, the automotive industry and energy service providers. Over 400 employees in 6 subsidiaries work together to ensure state of the art solutions for our clients.

We are looking for new colleagues in Qualysoft teams for diverse projects providing continuous learning opportunities. Our common goal is to provide honesty, development and a stable background while getting to know the latest technologies. We are waiting for your application for the position below!

We are seeking an experienced GxP Compliance & Validation Planning Consultant to support a large-scale SAP S/4HANA transformation program within a regulated environment.

The consultant will be responsible for leading and coordinating validation planning, GxP compliance strategy alignment, and quality governance activities across the program. This is a non-configuration, non-development, and non-execution role focused on planning, advisory, coordination, documentation oversight, and ensuring alignment with regulatory expectations and internal quality standards.

The role will work closely with Quality, IT, PMO, System Integrator, Business Process Owners, and Validation teams to ensure the program maintains a compliant and inspection-ready approach throughout the implementation lifecycle.

Support the development and maintenance of the overall GxP and validation strategy for the SAP S/4HANA program

Coordinate validation planning activities across workstreams, releases, and deployment phases

Ensure alignment with applicable GxP regulations, internal quality standards, CSV/CSA methodologies, and data integrity principles

Advise program leadership on compliance impacts, validation expectations, and regulatory considerations related to system implementation activities

Support definition of validation deliverables, governance processes, and documentation requirements

Review and provide guidance on validation-related plans, deliverable structures, and compliance approaches prepared by implementation teams

Facilitate collaboration between Quality Assurance, IT, business stakeholders, and system integrator teams

Support risk assessment planning and traceability strategy discussions for GxP-relevant processes and systems

Participate in governance forums, quality reviews, and project planning sessions to ensure compliance activities are appropriately integrated into the program timeline

Monitor validation readiness and identify potential compliance gaps, risks, or dependencies requiring escalation

Support audit and inspection readiness activities related to the program

Provide oversight and coordination for validation scheduling, dependencies, and milestone tracking

7+ years of experience in GxP-regulated environments

Strong experience supporting validation and compliance activities for large enterprise system implementations

Experience with SAP ERP or SAP S/4HANA transformation programs

Solid understanding of GAMP 5, CSV/CSA methodologies, FDA 21 CFR Part 11, EU Annex 11, data integrity principles, and risk-based validation approaches

Experience coordinating cross-functional stakeholders in complex program environments

Familiarity with validation lifecycle documentation and governance processes

Experience in pharmaceutical, biotechnology, or medical device industries

Experience working within global transformation programs

Familiarity with regulated supply chain, manufacturing, quality, or laboratory processes

Prior experience working alongside System Integrators on ERP implementations