The Validation Lead acts as the key point of contact for cross-functional collaboration and communication with QA, IT, Business, and System Owners to ensure compliance with global regulations and internal quality standards.
Lead the development and execution of comprehensive validation strategies for systems, processes, software, and equipment, ensuring alignment with regulatory requirements such as FDA 21 CFR Part 11, EU Annex 11, and GAMP5.
QA, IT, Engineering, Business, Development) to define validation scope, priorities, and resource needs.
Maintain traceability and audit readiness of all validation deliverables, ensuring proper documentation management and compliance.
Manage training compliance for validation teams and project stakeholders; ensure that roles are trained appropriately per project and regulatory needs.
Support internal and external audits and inspections by preparing validation evidence and leading the response to validation-related inquiries.
Mentor junior validation staff and drive continuous improvement initiatives to enhance validation efficiency and compliance.
Bachelor’s or Master’s degree in Life Sciences, Engineering, Computer Science, or a related field.
~8+ years of validation experience within regulated industries (pharmaceuticals, biotech, or medical devices).
~ Proven leadership experience in managing validation projects across various platforms including LIMS, MES, ERP, CDS, QMS, and lab instruments.
~ Demonstrated ability to lead cross-functional teams and manage multiple projects simultaneously.
Knowledge and application of Computer Software Assurance (CSA) principles.
Experience managing global or multi-site validation projects.
Lean Six Sigma or Quality certifications (e.g.,