Quality & Compliance executive with 31+ years in Pharmaceutical companies
United States of America
Regulatory Affairs ■ Compliance and Risk ■ Process Improvement ■ Global Team Management Operational Leadership ■ Manufacturing ■ Supply Chain ■ Change Management ■ R&D Global Quality Assurance Executi...see more
Biotech, Pharma & Life Sciences
C-Level & Leadership
Risk & Compliance
Confirmed hourly rate
Available on short notice
Technical Director Quality Assurance Facilities & Validation
Jan 2021 - Present
For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical c...see more
Director, Computer System validation, Quality Systems and Compliance Head
May 2018 - Jan 2021
The Global Compliance and Quality System Lead reports to the Global Development Quality Compliance Head, GDQ, and is accountable for global compliance, quality system and computer valid...see more
Director of Quality Assurance, Compliance & Regulatory Affairs (CMO, R&D & Submissions)
Amring Pharmaceuticals Inc.
Nov 2015 - May 2018
Responsible for providing strategic plans and driving quality compliance oversight for US Quality Assurance functions to ensure compliance to Good Manufacturing Practices and policies. ...see more
Director of Quality Assurance Operations & Compliance
Pii (Pharmaceutics International, Inc.).
Nov 2014 - Dec 2015
Ensure compliance to cGMPs and managing area of responsibility while assuring the effective and timely response to the needs of the organization.
Manager Quality Assurance, Compliance, Tech Transfer & Supply Chain Management
Jun 2013 - Dec 2014
Oversight for External Manufacturing (CMOs), External Testing Laboratories (CTLs)
Support Quality activities for release and distribution, act as the Thrombogenics Project Quality repr...see more
Manager Quality Assurance, Quality Management Systems & Compliance
Apr 2010 - Jun 2013
Review, approval and closure of change controls, deviations, investigations, and CAPAs, as they pertain to Drug substance and Drug product for Xiaflex/Xiapex and Testim.