Kathy Simon Email & Phone Number

Paris, Fr

Somerset, Nj, Us

Durham, North Carolina, Us

Melbourne, Victoria, Au

Rahway, 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

Rahway, 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

• 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

• 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

Gaithersburg, Maryland, Us

Us

Phd, Biochemistry

Bs, Biology