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@alvogen.com
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2 phones found area 215 and 510
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LinkedIn matched
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Chuck Mccarthy is listed as Expert in FDA Warning Letter / Consent Decree closeout program design, control and cost optimization based in New York City Metropolitan Area, United States. AeroLeads shows a work email signal at alvogen.com, phone signal with area code 215, 510, and a matched LinkedIn profile for Chuck Mccarthy.
Chuck Mccarthy previously worked as President at American Pharmaceutical Consulting Inc. and Sr. Director, Tech Ops Strategic Initiatives and Performance Management at Impax Laboratories. Chuck Mccarthy holds Mba And Bs Chemical Engineering from Clarkson University.
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Straight line path to Warning Letter closeout. Remediation cost and scope analysis. Maximum readiness for reinspection. Mistakes to avoid. Remediation program planning and cost control. Organizational change.Our agency assesses and repairs or creates Quality Management Systems across all pharmaceutical dosage forms, brand, generic, small molecule, biopharm, Rx and OTC drugs, nutraceuticals and cosmetics. Active in the US, Middle East, EU, Taiwan and India.Available to give directional advice before formally engaging to contribute to your FDA Manufacturing Quality Warning Letter remediation program.
Listed skills include Gmp, Fda, Pharmaceutical Industry, Quality System, and 3 others.
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Founded and lead an International Pharmaceutical Agency specializing in FDA manufacturing Quality Warning Letter remediation. Sourced and deployed Laboratory and Manufacturing quality experts for international clients.
San Francisco Bay Area
• Led corporate strategic programs in U.S. and Taiwan for solid dose generic pharmaceutical manufacturer• Led Sales and Operations Planning (S&OP) business process for the CEO. • Transitioned plant-based supply chain planning processes to centralized Global Supply Chain Office through SAP Business Warehouse, Adexa Supply Chain Planning software and SAP IBPi. • Led closure of two manufacturing facilities• Transitioned ownership of newly acquired divestiture products• Led creation of an Irish corporate entity as an offshore intellectual property domicile• Designed and implemented Cognos Business Intelligence tools to deploy Balanced Scorecards across the global manufacturing network
San Francisco Bay Area
Co-directed (with the Senior Vice President of Quality) a successful program to close out an FDA Warning Letter• Facilitated FDA response drafting • Planned and managed third party compliance audits. • Directed planning and control of 200 remediation projects at U.S. and Taiwan manufacturing sites • Sourced and deployed 180 remediation contractors to augment internal resources• Administered Company remediation cost center and managed cash run rate for two years at U.S. and Taiwan sites. Underwent successful financial audit• Saved $10 million in remediation costs through bill rate negotiation, contractor control and scope levelling• Managed third party certifications of key Quality processes • Created and chaired Remediation Governance Committee• Chaired Employee Engagement / Quality Culture turnaround initiative
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Chuck Mccarthy is listed as Expert in FDA Warning Letter / Consent Decree closeout program design, control and cost optimization.
AeroLeads has found 1 work email signal at @alvogen.com for Chuck Mccarthy.
AeroLeads has found 2 phone signal(s) with area code 215, 510 for Chuck Mccarthy.
Chuck Mccarthy is based in New York City Metropolitan Area, United States.
Chuck Mccarthy has worked for American Pharmaceutical Consulting Inc., Impax Laboratories, Alvogen, Allergan, and Wyeth Pharmaceuticals.
You can use AeroLeads to view verified contact signals for Chuck Mccarthy, including work email, phone, and LinkedIn data when available.
Chuck Mccarthy holds Mba And Bs Chemical Engineering from Clarkson University.
Chuck Mccarthy is listed with skills including Gmp, Fda, Pharmaceutical Industry, Quality System, Internal And External Negotiation And Influence, Strategic Operations Summit And Event Planning And Chair, and Responding To Complex Inquiries From Management And Regulatory Agencies.
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