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Ken Paddock

Director Global Quality Sterility Assurance @Merz Aesthetics

Antioch, IL, US
MOBILE NUMBERS
+18•••••••45

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WORK HISTORY

Jan 2025 — Present

Director Global Quality Sterility Assurance @Merz Aesthetics

SKILLS

FdaCapaValidationGlpGmpPharmaceutical IndustryV&VSterilization21 Cfr Part 11SopRegulatory AffairsMedical DevicesDmaicBiotechnologyChange ControlAseptic ProcessingMicrobiologyLifesciencesQuality AssuranceQuality ManagementRegulatory RequirementsBiopharmaceuticals

ABOUT KEN PADDOCK

With over three decades in the healthcare industry, I specialize in sterility assurance specifically terminal sterilization, microbial control and quality management, currently serving as Director of Global Quality Sterility Assurance at Merz Aesthetics. Passionate about strengthening sterility assurance competencies, I aim to drive innovation and uphold rigorous standards that align with the organization’s commitment to safety and excellence. My mission is to contribute to global health by ensuring effective, quality-driven practices across all processes. At Merz Aesthetics, I lead the development and execution of sterility assurance strategies, focusing on risk mitigation and compliance. By integrating global policies and collaborating with cross-functional teams, I enable sustainable improvements in sterility assurance measures. My expertise spans strategy development, risk evaluation, and competency enhancement, ensuring operational excellence and regulatory alignment.Industry involvement includes serving as Chair Elect of the PDA Science Advisory Board, where I help guide strategic initiatives to advance scientific excellence in the pharmaceutical and biopharmaceutical sectors. In addition to this leadership role, I actively contribute as a PDA Chapter Board member and serve as a Chapter Ambassador, promoting collaboration, knowledge sharing, and global harmonization of best practices. My work reflects a dedication to strengthening industry standards and supporting professional development across the PDA community.

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