The Opportunity:

• Support the development, implementation, and continuous improvement of the global GxP Document Management Program, ensuring document control processes, governance, and systems remain compliant, efficient and aligned with regulatory requirements and industry standards.

• Review and coordinate Document Change Controls (DCCs) and document workflows to ensure GxP procedures, forms, templates, and other controlled documents are managed throughout their lifecycle in accordance with global requirements and company procedures.

• Serve as the subject matter expert (SME) for the electronic Document Management System (eDMS/eQMS), driving global standardization, governance, system optimization, user support, and continuous improvement initiatives.

• Partner cross-functionally with global RevMed functions, sites, and affiliates to evaluate document management process effectiveness, identify improvements, and implement sustainable solutions that enhance the operational excellence.

• Support strategic document management initiatives, including workflow optimization, system enhancements, document migrations, periodic reviews, global expansion activities, training programs, and process improvement projects.

• Monitor, analyze, and communicate key quality metrics and KPIs related to document lifecycle management and process performance, driving appropriate corrective and preventive actions.

• Support the development, implementation, and maintenance of global SOPs, work instructions, governance frameworks, and best practices supporting document management of quality systems while promoting process consistency, governance, and user adoption.

• Support internal audits, regulatory inspections, and inspection readiness activities and foster a culture of quality, accountability, and continuous improvement.

Required Skills, Experience and Education:

• BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience and education.

• Minimum 5 years of Pharma/Biotech industry experience in Quality Assurance (QA) in a GxP environment.

• Experience in developing and implementing GxP quality systems to meet current regulatory and industry standards.

• Direct experience managing global GxP document management and training systems.

• Excellent working knowledge and understanding of GxP requirements, proficiency in applying regulatory requirements, and ICH guidelines.

• Direct experience working with Veeva QualitySuite electronic platforms (QualityDocs, Training, QMS).

• Proficient with Microsoft Office including Word, Excel, PowerPoint experience is a plus.

• Excellent communication skills, both oral and written to clearly and concisely communicate with internal and external team members.

• Ability to work independently and collaboratively across cross-functional teams in a dynamic environment

Preferred Skills:

• Strategic thinking and project management skills.

• Direct experience with handling and/or participating in regulatory body inspections.

• A continuous improvement mindset and willingness to take initiative in solving problems.

• Experience in both virtual sponsor and scaling global organization models. 

  #LI-Hybrid #LI-JC1