John McKay Email & Phone Number
President, Chief Business Development, Operations, Quality, Regulatory Affairs, Clinical Officer @ Q1 Associates LLC
5 free lookup(s).
John McKay Location
- San Diego, CA, US
John McKay Work
- 2023 - now President, Chief Business Development, Operations, Quality, Regulatory Affairs, Clinical Officer @
- 2020 - 2023 VP Quality @
- 2016 - 2020 Chief Operating, Quality, and Technology Officer @
- 2016 - 2019 SVP Global QA and Chief Compliance Officer (Expatriate) @ Zhejiang Hisun Pharmaceutical Co., Ltd
- 2014 - 2016 Member Board of Directors @
- 2014 - 2016 Senior Vice President, Global Quality and Chief Compliance Officer @
- 2012 - 2014 Global Vice President, Quality Assurance and Regulatory Affairs @ Pathfinder Therapeutics, Inc. is now Pathfinder Technologies, Inc.
- 2007 - 2011 Vice President, Quality and EHS @ BioMimetic Therapeutics
- 2007 - 2007 Senior Director, Compliance @
- 2006 - 2007 Global Manager, Operational Excellence and Auditing @
- 2002 - 2006 Manager, Operational Excellence @
- 2000 - 2002 Project Manager, Operational Excellence @
- 1996 - 2000 Regional Manager, EHS and Training @
- 1995 - 1996 Global Environmental Issue Manager @
- 1993 - 1995 Manager, Manufacturing Excellence @
- 1991 - 1993 Technical Services Manager @
- 1990 - 1991 Environmental Manager @
- 1988 - 1990 Plant Manager @
- 1987 - 1988 Operations Manager @
- 1986 - 1988 Production Engineer @
- 1985 - 1986 Process Engineer @
John McKay Education
- Temple University Graduate School
Postgraduate Degree (Post-Master’s Certificate in Biosimlars and Generic Drugs)
2024 - 2025 - Randallstown High School 2024 - 2025
- Temple University Graduate School
Master of Science - MS (Regulatory Affairs and Quality Assurance (RAQA))
2017 - 2020 - Temple University School of Pharmacy
Drug Development Certificate (Regulatory Affairs and Quality Assurance (RAQA))
2017 - 2018 - Pittsburgh Bartender School
Bartender Certification Certified Mixologist (Bartending/Bartender)
2006 - 2006 - University of Pittsburgh Katz Graduate School of Business
Project Management Professional (PMP) Diploma - Project Management Institute (Project Management Professional (PMP))
2001 - 2001 - Disney Institute 2000 - 2000
- Leadership Charleston
Executive Leadership and Community Development (Business Administration and Management, General)
1997 - 1998 - The Wharton School
MBA Diploma (Business Administration)
1990 - 1992 - Penn State University
BS (Chemical Engineering)
1981 - 1985
John McKay Skills
- Business Development
- Business Strategy
- Business Planning
- Business Process Improvement
- Business
- Patient Safety
- Failure Mode and Effects Analysis (FMEA)
- SQC
- Statistical Process Control (SPC)
- Certified GMP Professional
- Supplier Audits
- Good Distribution Practice (GDP)
- RQAP-GCP
- CMQ/OE
- Certified Quality Auditor (CQA)
- Corrective Action and Preventive Action (CAPA)
- Root Cause Analysis
- Management Review
- Effectiveness Check
- Total Quality Management (TQM)
- Trial Master File (TMF)
- Electronic Trial Master File (eTMF)
- Quality Management System
- Learning Management Systems
- Training Management System
- Electronic Document Management System (EDMS)
- Document Management Systems (DMS)
- Information Systems
- Qualified Person
- Responsible Person
- Regulatory Affairs
- Regulatory Compliance
- Operations Management
- Chemistry, Manufacturing, and Controls (CMC)
- Chief Operating Officer
- Chief Regulatory Affairs Officer
- Clinical Trial Management System (CTMS)
- Clinical Affairs
- Clinical Operations
- Risk Management
- Consulting
- Auditing
- Inspection Readiness
- Product Development
- Product Approval
- Product Commercialization
- Pharmacovigilance
- Good Manufacturing Practice (GMP)
- Good Clinical Practice (GCP)
- Leadership
- FDA
- Quality Assurance
- Quality Auditing
- Quality Management
- Quality Systems
- ISO 13485
- Operational Excellence
- ISO 14001
- Supply Chain Management
- Corporate Governance
- Supply Chain
- Six Sigma
- Lean Manufacturing
- Manufacturing
- Customer Satisfaction
- ISO 9001
- Environmental Compliance
- Environmental
- Environmental Management
- Kaizen
- Customer Acquisition
- ISO standards
- Customer Retention
- Social Media Marketing
- Manufacturing Management
- Corporate Social Responsibility
- Executive Management
- Customer Service
- Chief Compliance Officer
- Chief Quality Officer
- Board
- Executives
- Quality
- Compliance
- Quality Agreement
- ISO 14971
- CE Marking
- PMA
- Corporate Management
- Contract Manufacturing
- Supplier Management
- ISO 22000
- OHSAS 18001
- OSHA
- Customer Focus
- Safety
- Vice President
- Kaizen Facilitation
- Hazard Analysis & Critical Control Points (HACCP)
- Corporate Integrity Agreement
- Scouting
- Public Speaking
- Hazard Analysis And Critical Control Points Haccp
- Project Management
- Continuous Improvement
John McKay Summary
- John McKay, based in San Diego, CA, US, is currently a President, Chief Business Development, Operations, Quality, Regulatory Affairs, Clinical Officer at Q1 Associates LLC. John McKay brings experience from previous roles at Travere Therapeutics, Q1 Associates LLC, Zhejiang Hisun Pharmaceutical Co., Ltd and CTI BioPharma. John McKay holds a 2024 - 2025 Postgraduate Degree in Post-Master’s Certificate in Biosimlars and Generic Drugs @ Temple University Graduate School. With a robust skill set that includes Business Development, Business Strategy, Business Planning, Business Process Improvement, Business and more. John McKay has 1 emails and 1 mobile phone numbers on RocketReach.
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