Responsibilities
- Assist in creating and maintaining the GxP and validation strategy for the SAP S/4HANA initiative
- Coordinate validation planning across multiple workstreams, release cycles, and deployment stages
- Ensure compliance with relevant GxP regulations, internal quality policies, CSV/CSA practices, and data integrity standards
- Advise senior program leads on regulatory implications, validation requirements, and compliance aspects tied to system deployment
- Help define validation outputs, governance procedures, and documentation criteria
- Review and guide validation plans, document frameworks, and compliance strategies developed by implementation groups
- Promote cooperation among Quality Assurance, IT, business units, and system integration teams
- Support planning for risk assessments and traceability strategies for GxP-impacted processes and systems
- Engage in governance meetings, quality evaluations, and project planning to integrate compliance tasks into project timelines
- Track validation preparedness and detect compliance shortfalls, risks, or interdependencies needing escalation
- Assist in preparing for audits and regulatory inspections related to the program
- Oversee and coordinate validation scheduling, dependencies, and milestone progress tracking
Benefits
- Individuals are valued and always welcome to share input
- Team collaboration and transparency are core cultural principles
- Innovation and fresh perspectives are encouraged, as stagnation is not part of the workplace ethos
Benefits
- You count as a person, our doors are always open
- We live the Qualysoft Team Spirit and stand for transparency
- Fresh wind and new ideas are welcome, because standstill is a foreign word at Qualysoft
