Job Description

Responsibilities:

• Lead and manage change control processes for S/4HANA implementation in alignment with GxP and related SOPs.
• Review project timelines to ensure sufficient time is allocated for GxP validation activities and documentation deliverables.
• Prepare and maintain validation documentation (URS, FRS, IQ/OQ/PQ, Traceability Matrix, etc.).
• Coordinate and support E-CAB and Stage Gate meetings, including presentation preparation.
• Facilitate review and approval cycles with QA and business stakeholders.
• Ensure compliance with tools and systems such as ALM, ISM, Track Wise, and VEEVA CDOS.

Requirements:

• 12+ years of experience in IT Change Management or Validation roles, preferably in life sciences or other regulated industries.
• Strong understanding of GxP, CSV, and regulatory compliance frameworks.
• Familiarity with validation tools and documentation standards.
• Excellent communication and coordination skills.
• Experience working with cross-functional teams including QA, PMO, and business stakeholders.
• Experience with ERP implementations.
• Experience supporting audit readiness and inspection processes.

Additional Information

All your information will be kept confidential according to EEO guidelines.