Justine Schenck
Senior Quality Assurance Manager, Qa Lead @Milestone Pharmaceuticals, Inc
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WORK HISTORY
Senior Quality Assurance Manager, Qa Lead @Milestone Pharmaceuticals, Inc
US
Key responsibilities and accomplishments include:• Leading the implementation and continuous improvement of Milestone’s Combination Product Quality Management System (QMS)• Driving QMS ownership and alignment across internal functions and external partners• Overseeing GxP compliance across clinical, manufacturing, and commercial activities• Managing GxP vendor oversight, including audits, quality agreements, deviations, and documentation• Leading Pre-Approval Inspection (PAI) readiness, execution, and post-inspection resolution• Coordinating inspection interactions and regulatory communication strategies• Overseeing the Quality Incident and Corrective and Preventive Action (CAPA) program• Providing oversight of the GxP training program• Managing change control, design and development quality oversight, and document lifecycle processes• Supporting commercial batch record review and release-to-market processes• Leading product quality complaint investigations and resolution• Acting as a strategic quality leader during a critical phase of regulatory approval and commercial launch readiness
EDUCATION
Temple University
Master of Science (M.S.)
University of the Sciences in Philadelphia
Bachelor's degree
SKILLS
ABOUT JUSTINE SCHENCK
I’m a strategic and systems-focused Quality Assurance leader with 10+ years of experience…
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