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Forward thinking, results driven senior Biotechnology Leader with extensive strategic and operational experience leading Regulatory, Quality, and Operations professionals empowered with developing pathways to accelerate development plans and commercialize products. 20+ year career includes a multi-dimensional background of negotiating regulatory issues with worldwide regulators, establishing and improving quality systems and procedures to ensure the quality of products and processes, and developing and implementing clinical and commercial manufacturing processes in the areas of small molecules, large molecules and vaccines. Specialties: Regulatory Affairs and Quality Assurance • Advertising, Promotion, Labeling • GXP Compliance • Conduct of Internal and 3rd Party Audits • FDA Inspection Strategies and Negotiations • Drug Development Requirements (FDA, EU, ICH) • FDA and Board-level Presentations • Development and Supervision of Departments • Drug Development Strategies (CMC, Clinical & Non-clinical) • Clinical Protocol Development • International Drug Registration ( Master Files, IND, BLA, NDA, CTA/IMPD, MAA) • Product Commercialization • Manufacturing Operations • Lean Six Sigma.
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Vice President Global QualityCellectis Jun 2024 - PresentParis, Fr -
Head Of Quality Gene TherapyCatalent Pharma Solutions Jun 2023 - May 2024Somerset, Nj, Us -
Adjunct Faculty InstructorDuke University Nov 2015 - Jun 2023Durham, North Carolina, Us -
Vice President Quality ControlMedicago Apr 2021 - Apr 2023
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Senior Director Network StrategyCsl Behring Sep 2020 - Apr 2021Melbourne, Victoria, Au -
Global Quality Management SystemMerck Oct 2018 - Sep 2020Rahway, New Jersey, Us• Global accountability for cross functional alignment for transforming Merck’s Quality Management System across Human Health sites• Drive behavior and cultural changes throughout organization• Lead development and execution of significant innovation projects driving operational improvements related to all the topics• Develop and implements the strategy for the quality organization and management responsibilities processes and systems that is enabled by IT solutions to ensure sustainable compliance of all MMD sites and functions • Provide leadership and technical direction on regulatory requirements for quality organization and management responsibilities processes and associated support systems• Lead development and execution of significant innovation projects driving operational improvements -
Director Quality OperationsMerck Jan 2013 - Oct 2018Rahway, New Jersey, Us• Site lead for implementation of global initiative to transform the Quality Management System• Executed site strategy for transferring new products and gaining approval in global markets resulting in expansion of supply into 32 distinct markets for 5 products in 18 months• Accountability for strategic and tactical and strategic aspects of site Quality oversight at live viral vaccine site as the Site Quality Head• Key site leader with proven ability to influence others to reach common goals as well as act independently • Provides thorough and timely assessments and updates to Senior and Executive Leadership to ensure efficient communication and seamless cross functional collaboration• Proactively identifies and solves complex problems that impact the direction of the business at both site and global levels• Responsible for site wide Quality Systems including Deviation Management, CAPAs, Change Control, Supplier Management, Complaints, Audits and Inspections• Approval of all Regulatory filings for Live Viral Vaccines worldwide• Manage all Agency notifications regarding quality issues, inspections, submission reviews and communications• Effectively manage staffing including hiring, discipline, rewards and recognition, and effective human capital resource allocation
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Head Of ManufacturingDiosynth Feb 2010 - Jan 2013• Provided technical and strategic input for business development including new offerings, capital investments, and business processes.• Provide input and recommendations for strategic planning and expansions, including new offerings, shift expansions, and facility expansions• Ensure total annual business revenues are met and achieve monthly and quarterly forecasts• Assured alignment with clinical and commercial team, as well as commercial Business Development colleagues for activities and needs relating to strategic business initiatives• Led cross functional integrated Operations team consisting of manufacturing, planning, purchasing, maintenance, and analytical testing.• Ensure operational aspects in production and warehouse including productivity, cost, continuous improvement and regular business processes• Effectively manages staffing including hiring, discipline, rewards and recognition, and effective human capital resource allocation
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Director Upstream Processing & DevelopmentDiosynth May 2009 - Feb 2010• Manage and direct employees and functions of the production, development and warehouse operations area• Direct operational aspects in production and development areas, including productivity, cost, continuous improvement and regular business processes• Ensures compliance with all applicable corporate and regulatory SOP, cGMP, and safety guidelines• Participates and represents Company in FDA audits and inquires• Develop and achieve annual budget for Operations
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Associate Director Regulatory ComplianceDiosynth Dec 2007 - May 2009
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Manager, Worldwide Regulatory CmcMedimmune 2004 - 2006Gaithersburg, Maryland, Us -
QualityNalge Nunc International 1999 - 2001Us
Kathy Simon Skills
Kathy Simon Education Details
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Virginia TechBiochemistry -
George Mason UniversityBiology
Frequently Asked Questions about Kathy Simon
What company does Kathy Simon work for?
Kathy Simon works for Cellectis
What is Kathy Simon's role at the current company?
Kathy Simon's current role is Vice President Global Quality.
What is Kathy Simon's email address?
Kathy Simon's email address is si****@****ago.com
What schools did Kathy Simon attend?
Kathy Simon attended Virginia Tech, George Mason University.
What skills is Kathy Simon known for?
Kathy Simon has skills like Biopharmaceuticals, Biotechnology, Technology Transfer, Vaccines, Validation, Fda, Aseptic Processing, Pharmaceutical Industry, Sop, Fermentation, Protein Chemistry, Glp.
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