GxP Validation Manager

5 days ago


Rockville, Minnesota, United States REGENXBIO Inc. Full time

At REGENXBIO Inc., we are seeking a highly skilled GxP Validation Manager to oversee all aspects of our validation program/team.

This position will be responsible for managing the qualification of GxP equipment, including analytical equipment, controlled temperature units, GMP manufacturing equipment, and GxP computer systems.

The ideal candidate will have a strong understanding of validation requirements, practices, and procedures, as well as the ability to instruct others participating in validation activities.

The GxP Validation Manager will be responsible for:

  • Managing the development, collaboration, and review of validation deliverables for equipment and computer systems used in GxP laboratories and manufacturing.
  • Overseeing the timely completion of all validation documentation, including coordination of contractor activities.
  • Interacting with other departments to facilitate validation activities as needed.
  • Managing the creation and execution of validation protocols in accordance with SOPs and industry standards.
  • Initiating, owning, and reviewing change controls for validated laboratory, production, and other GxP related systems.
  • Ensuring all validation documents achieve the goal of traceability and risk acceptance.
  • Overseeing troubleshooting and investigations of validated systems.
  • Leading periodic reviews of systems to ensure they are maintained in a validated state.
  • Ensuring compliance with all applicable GxP regulations as well as appropriate SOPs.
  • Leading development and continuous improvement initiatives.

The successful candidate will have a minimum of 5 years of validation experience or 3 years of validation experience and a graduate degree. They will also have a working knowledge of cGMP, GLP, 21CFR11, and industry best practices.

We offer a comprehensive and competitive benefit plan, including market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, and more.

At REGENXBIO Inc., we are committed to providing our employees with opportunities for professional growth and development. We believe that our employees are our greatest asset, and we are dedicated to supporting their success.


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