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.
Remote Work :
No
Employment Type :
Contract