Senior QA Specialist, Global Document Control Management

Role: Senior Quality Assurance specialist responsible for developing, implementing, and maintaining the global GxP Document Management Program within a late-stage oncology biotech focusing on RAS-targeted therapies. Responsibilities include managing document workflows, coordinating Change Controls, serving as SME for electronic Document Management Systems (Veeva QualitySuite), and supporting global SOPs, training, audits, and inspection readiness. Qualifications: BA/BS in Biological Sciences or related field; 5+ years of QA experience in GxP environments within Pharma/Biotech; proficient with GxP standards, Veeva platforms, and regulatory guidelines. Preferred: strategic project management skills, experience with regulatory inspections, continuous improvement mindset, and global organization experience. HighValue: GxP quality systems, document lifecycle management, Veeva QualitySuite, global quality governance, and audit support. WorkSetup: not specified.