Kelly C.

Kelly C. Email and Phone Number

Experienced Pharma Quality Leader | MBA, PMP | Expert in Regulatory Compliance & Process Improvement. QA, QC, QMS, Medical Device, Validation. @ Grand Canyon University
United States
Kelly C.'s Location
United States, United States
Kelly C.'s Contact Details
About Kelly C.

Quality professional with expertise to translate regulatory requirements (FDA, ICH, EU) into workable compliant programs. Head Quality System Program. API & DP & Medical Device Technical Transfer. Leader & team builder. Validation expert. Resource management. Best practice contributor as well as author of corporate standards. Trainer Responsible and coach for high skilled areas and processes with results in compliant manufacturing, software, and laboratory quality systems. Research and development Scientist in Immunology, Inflammation, Molecular Biology, Pathology and Diagnostics. Experimental Design, method development & transfer, testing, sterile cell culture. Gene therapy.

Kelly C.'s Current Company Details
Grand Canyon University

Grand Canyon University

View
Experienced Pharma Quality Leader | MBA, PMP | Expert in Regulatory Compliance & Process Improvement. QA, QC, QMS, Medical Device, Validation.
United States
Kelly C. Work Experience Details
  • Grand Canyon University
    Grand Canyon University
    United States
  • Bayer
    Associate Director Divisional Quality
    Bayer May 2016 - Present
    Leverkusen, North Rhine-Westphalia, De
    Responsible for Capitol and Strategic Projects over five million euro. Quality Expert API & DP, Medical Device. Technical Transfer phase and requirement review. Responsible Divisional Training. Quality System Alignment Global Head.
  • Genentech
    Quality Program Manager/ Quality Engineer
    Genentech Aug 2005 - May 2016
    South San Francisco, California, Us
    Quality professional with expertise to translate regulatory requirements (FDA, ICH, EU) into workable compliant programs. Leader. Team builder. Validation expert. Resource management. Best practice contributor as well as author of corporate standards. Trainer and coach for high skilled areas and processes with results in compliant manufacturing, software, and laboratory quality systems. Research and development in Immunology, Inflammation, Molecular Biology, Pathology and Diagnostics. Experimental design, method development, testing, sterile cell culture.
  • Biogen
    Technical Project Manager
    Biogen Jan 2003 - Jan 2005
    Cambridge, Ma, Us
  • Idec
    Stability Sr. Associate
    Idec Jan 2001 - Jan 2003
  • Applied Molecular Evolution, Ame
    Development Scientist
    Applied Molecular Evolution, Ame Jan 1994 - Jan 2000
  • Ucsd
    Research Scientist
    Ucsd Jan 1990 - Jan 1994
  • Synbiotics Corporation
    Diagnostic Associate
    Synbiotics Corporation Dec 1988 - Jan 1990
    Kansas City, Missouri, Us
  • Immunetech Pharmacueticals
    Research Assistant
    Immunetech Pharmacueticals Sep 1987 - Dec 1988

Kelly C. Skills

Chromatography Quality Processes Sample Management Consulting Csv Suppliers Technical Reviews Master Plan Strategist In Vivo Vendors Data Entry Infectious Diseases 5s Waste Reduction Gxp Clinical Research Biotechnology Change Control Immunology Sipoc Streams U.s. Food And Drug Administration Ish Process Integration Singapore Deviations Sequencing Cross Functional Team Leadership Facilitation Immunohistochemistry Clinical Development Quality Auditing Japan Organizational Structure Assessment Marine Biology Procurement Management Site Work Design Delta V Science Security Mes Glp Technical Team Integration Sop 21 Cfr Part 11 Fab Cross Functional Alignment Leadership Auditing Row Use Case Gap 21 Cfr Lean Manufacturing Sdlc Human Resources Execution Financial Forecasting Molecular Evolution Hplc Gmp Antibodies Capas Networking Customer Satisfaction System Business Services Site Coordination Pcr Virology Network Integration Software Documentation Validation Team Leadership Pharmaceutical Engineering Engineering Strategy Apple Purchased Strategies Microsoft Office Pathology Process Control Testing Oncology Risk Management Founding Asq Gcp Drug Development Microsoft Excel Training Customer Service Exceeding Customer Expectations Audience Sla Order Fulfillment Root Cause Corrective And Preventive Action Streamline Documentation Project Management Product Development American Research Quality Control System Monitoring Pmp Cloning Shares Capital Commercial Real Estate Investigation Microsoft Lims Capa R&d Analysis Kepner Tregoe Molecular Advertising Agency Biopharmaceuticals Laboratory Business Partnering Design Control Comparative Analysis Sap Metabolism Validation Master Plans C Rfp Multi Product Computer System Validation Gamp Fix Protocol Accountability Applications Ispe Restful Web Services Communication Contemporary Art Modeling Resource Management Clinical Study Design Life Sciences Cell Culture European Union Erp Quality Assurance User Requirements Regulatory Requirements Increase Productivity Posters Author Molecular Biology Quality System Competition Swot Laboratory Skills Document Management Change Management Timelines Sow Instrument Validation Project Planning Remediation Project Sql Contractual Agreements House Facilities Management Technology Transfer Dmaic Data Acquisition Iso 13485 Responsibility Internal Audit Therapists Regulations International Multi Sites Certification Number Biology Glassware Root Cause Analysis Start Ups Teaching Reviews Ich Guidelines Vendor Management Diagnostics Process Improvement Bridge Inspection Medical Devices Software San Diego Technical Writing Compliance Arizona Product Lifecycle Management Pmi Work Instructions Program Management Pharmaceutics Business Process Manufacturing Internal Controls Asset In Vitro Annex 11 Libraries Stability Biologics Instructional Design Controlling Knowledge Management Risk Pharmaceutical Industry Acknowledgements Templates Summit Fda North American Automation Directed Evolution

Kelly C. Education Details

  • Grand Canyon University
    Grand Canyon University
    General
  • Arizona State University
    Arizona State University
    Biology
  • Cornell University
    Cornell University
    Marine Biology
  • Arizona State University
    Arizona State University
    General
  • Arizona State University
    Arizona State University
    General

Frequently Asked Questions about Kelly C.

What company does Kelly C. work for?

Kelly C. works for Grand Canyon University

What is Kelly C.'s role at the current company?

Kelly C.'s current role is Experienced Pharma Quality Leader | MBA, PMP | Expert in Regulatory Compliance & Process Improvement. QA, QC, QMS, Medical Device, Validation..

What is Kelly C.'s email address?

Kelly C.'s email address is bi****@****hoo.com

What schools did Kelly C. attend?

Kelly C. attended Grand Canyon University, Arizona State University, Cornell University, Arizona State University, Arizona State University.

What skills is Kelly C. known for?

Kelly C. has skills like Chromatography, Quality Processes, Sample Management, Consulting, Csv, Suppliers, Technical Reviews, Master Plan, Strategist, In Vivo, Vendors, Data Entry.

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.