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Senior Validation Project Manager

2 months ago

San Mateo, California, United States Katalyst HealthCares & Life Sciences Full time
Senior Validation Project Manager

At Katalyst HealthCares & Life Sciences, we are seeking a highly skilled Senior Validation Project Manager to lead our Computer System Validation (CSV) efforts in support of our GxP quality and compliance environment for SAP S/4 HANA. This is a critical role that requires a strong understanding of GxP regulations, FDA and EMEA guidelines, and computer system validation principles.

Key Responsibilities:
  • Develop and execute validation plans for SAP S/4 HANA system
  • Lead the effort to manage and maintain validation of SAP S/4 HANA system
  • Perform GxP and 21 CFR Part 11 assessments and develop functional risk strategies
  • Review user business process documents and user requirements specifications
  • Prepare and review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols
  • Lead overall protocol executions, log, and track defects
  • Review executed test reports for proper documentation of test results and evidence
  • Prepare and maintain the traceability matrix to ensure all requirements are covered in design documents and tested
  • Participate in Corrective and Preventive Action (CAPA) and maintain quality metrics
  • Maintain overall project and issue tracker and report routinely
Requirements:
  • 8+ years of experience in Computer System Validation in Life Science domain with minimum 3+ years of experience in managing large global SAP validation projects
  • Excellent communication (oral and written) and attention to detail
  • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
  • Excellent knowledge of GxP regulations, FDA and EMEA guidelines, including 21 CFR Part 11
  • Excellent knowledge of computer system validation and GAMP-5 standards

We offer a dynamic and challenging work environment, competitive compensation, and opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.