Senior Validation Lead

4 days ago


Boston, Massachusetts, United States Katalyst Healthcares & Life Sciences Full time
About the Role

We are seeking a highly experienced Senior Validation Lead to join our team at Katalyst Healthcares & Life Sciences. As a key member of our team, you will be responsible for leading validation efforts for our Labvantage LIMS system.

Key Responsibilities
  • Lead validation efforts for Labvantage LIMS, ensuring compliance with GxP regulations and industry standards.
  • Collaborate with cross-functional teams to develop and implement validation strategies.
  • Manage and drive GxP and non-GxP deliverables, including authoring, executing, reviewing, and approving deliverables.
  • Develop and maintain best practices, guidelines, and checklists for GxP project execution.
  • Foster strong relationships with internal teams and customers to ensure effective communication and coordination.
  • Manage stakeholder expectations and ensure successful project delivery.
Requirements
  • Minimum 5 years of experience in validation lead roles, with a strong background in pharmaceutical companies.
  • Proven track record of managing teams to successful project delivery.
  • Excellent communication, coordination, and stakeholder management skills.
  • Strong understanding of GxP regulations and industry standards.
  • Experience with Labvantage LIMS, MES, and other relevant systems.
  • Hands-on experience with validation, testing, and project management.


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