GxP Validation Manager

2 weeks ago

Rockville, Maryland, United States REGENXBIO Inc. Full time
Job Summary

The Validation Manager will oversee all aspects of the validation program/team, ensuring compliance with GxP regulations and industry standards. This includes managing the development, collaboration, and review of validation deliverables for equipment and computer systems used in GxP laboratories and manufacturing.

Key Responsibilities
  • Manage the timely completion of all validation documentation, including coordination of contractor activities.
  • Interact with other departments to facilitate validation activities as needed.
  • Manage the creation and execution of validation protocols in accordance with SOPs and industry standards.
  • Initiate, own, and review change controls for validated laboratory, production, and other GxP related systems.
  • Ensure all validation documents achieve the goal of traceability and risk acceptance.
  • Oversee troubleshooting and investigations of validated systems.
  • Lead periodic reviews of systems to ensure they are maintained in a validated state.
  • Ensure compliance with all applicable GxP regulations as well as appropriate SOPs.
  • Lead development and continuous improvement initiatives.
Requirements
  • Minimum BA / BS or relevant work experience in engineering or science.
  • Minimum of 5 years of validation experience or 3 years of validation experience and graduate degree required.
  • Working knowledge of cGMP, GLP, 21CFR11, and industry best practices.
  • Working knowledge of ASTM E2500 and GAMP 5.
  • Strong communication (oral and written) and interpersonal skills.
  • Ability and willingness to work in a fast-paced environment.
Preferred Qualifications
  • Experience in pharmaceutical GxP operations.
  • Experience with electronic validation systems.
  • Experience with buildout of a manufacturing facility and moving laboratory spaces.
  • Experience with computer systems validation including Document and Quality Management Systems (eDMS and QMS), Enterprise Resource Planning (ERP), Laboratory Information Management Systems (LIMS), and Process Control Systems (PCS).
  • Computer system data mapping experience related to data integrity.
Why REGENXBIO

By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients.

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

In addition, professional development is important to us. By joining our team, you'll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally.

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