My Profile

MR John Lockwood, CSQE, RAC, ASQ-CQA

Contact Details

United States
CHAPTER CHAIR
Chapter Officer
RegEx Pro

Bio

John Lockwood serves as Director, QA/RA Services for Pearl Pathways. He has over 24 years of experience in quality, regulatory, validation, auditing, and purchasing roles in the life sciences industry. In addition to holding a variety of positions within small and large medical device manufacturers, he also brings a decade of experience in consulting and operations. Prior to joining Pearl Pathways, John led the quality function at an Indianapolis based laser medical device company. Much of his career was spent working for large multi-national companies including Abbott and Roche. He has held roles including QA/RA Director, Technical Specialist, R&D Project Manager, Operations Team Lead, Quality Control Manager, Test Method Validation Manager, Supplier Quality Engineer, Lead Auditor (for several Registrars / Notified Bodies), Director of Quality Assurance and Regulatory Affairs, and Purchasing Manager. As a Senior Advisor, John is responsible for the development of regulatory strategies and filings, quality assurance programs, global health authority interactions, evaluation of facilities for compliance, and leading cross-functional teams. Furthermore, he leads Pearl Pathways’ audit team and medical device practice. John’s specialties include quality assurance, internal and external audits, control and purchasing, regulatory strategy, operations, project management, lead auditor roles, and product development. John is ANSI-RAB NAP Accredited Lead Auditor, has a Regulatory Affair Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and is a Certified Quality Auditor Certification (CQA) and Certified Software Quality Engineer (CSQE) from the American Society of Quality (ASQ). In the past, he also received his Certified Purchasing Manager (CPM) from the Institute of Supply Management. John has a Bachelor’s of Science degree in Chemistry from the University of Illinois.

Education

University of Illinois
Champaign-Urbana, Illinois, United States
BS, 1993
Chemistry

Year Entered Profession

  • 1990-1994

Current Organization Type

  • Consulting Firm

Job History

Senior Advisor
May 2015 - present

Director, Quality Assurance and Regulatory Affairs
Indianapolis, IN
August 2014 - May 2015

Associate Director
Indianapolis, IN
May 2008 - August 2014

Quality Manager
Indianapolis, IN
August 2001 - May 2008

Group Leader
North Chicago, IL
June 1994 - August 2001

Highest Degree Earned

  • Baccalaureate

Regional Interests

  • Worldwide

Product Interests

  • API's
  • Biologics
  • Biomaterials
  • Biosimilars/Generic
  • Biotechnology
  • Combination Products
  • Cosmetics
  • Generic Drugs
  • IVDs
  • Medical Devices
  • Orphan Products
  • OTC drugs

Product Interests

  • API's
  • Biologics
  • Biomaterials
  • Biosimilars/Generic
  • Biotechnology
  • Combination Products
  • Cosmetics
  • Generic Drugs
  • IVDs
  • Medical Devices
  • Orphan Products
  • OTC drugs

Regional Interests

  • Worldwide

Year Entered Profession

  • 1990-1994

Current Organization Type

  • Consulting Firm

Highest Degree Earned

  • Baccalaureate