Katalyst Healthcares and Life Sciences
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.
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.