Senior QA Specialist, Global Document Control Management

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The companys RAS(ON) inhibitors daraxonrasib (RMC-6236) a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291) a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805) a RAS(ON) G12D-selective inhibitor; and RMC-5127 a RAS(ON) G12V-selective inhibitor are currently in clinical development. As a new member of the Revolution Medicines team you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

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.

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