Christine Janes
Associate Director, Quality Compliance @Andelyn Biosciences
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WORK HISTORY
Associate Director, Quality Compliance @Andelyn Biosciences
Columbus, OH, US
Lead Health Authority inspections and serves as primary Quality host, directing inspection strategy, SME preparation, response coordination, and post-inspection remediation.• Own and continuously enhance the enterprise Inspection Readiness Program across internal operations and external partners.• Direct the full audit lifecycle (internal, supplier, regulatory), standardizing risk classification and observation management to improve consistency and executive visibility.• Lead Supplier Quality Management program, overseeing vendor qualification, audit execution, performance monitoring, and risk mitigation strategies.• Manage and develop a team of auditors supporting global supplier oversight and internal audit execution.• Provide executive-level compliance risk assessments and escalate critical issues to senior leadership.• Oversee Document Control, Training Governance, and GMP documentation approval.• Support Quality Management Review by delivering compliance metrics and trend analysis.• Ensure budget alignment and resource optimization within Quality Compliance function.
EDUCATION
West Chester University of Pennsylvania
Bachelor's of Science, Forensic Chemistry
West Virginia University
Masters of Science, Safety engineering, Occupational Safety and Health
PennWest California
Bachelors of Science, Chemistry
ABOUT CHRISTINE JANES
With over 18 years of experience in pharmaceutical and biotech environments, I currently serve as Associate Director of Quality Compliance at Andelyn Biosciences. I lead critical functions such as Health Authority inspections, enterprise inspection readiness, and the Supplier Quality Management program. My work focuses on enhancing audit lifecycle processes, standardizing risk classification, and improving observation management to support regulatory excellence and operational efficiency. As a Certified Quality Auditor, my expertise spans GMP, compliance, audit execution, and vendor qualification. I am dedicated to fostering a strong quality culture, aligning quality strategies with business objectives, and mentoring high-performing teams. My mission is to build scalable, sustainable, and inspection-ready quality management systems that meet evolving regulatory requirements while enabling business growth.
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