Experience

Priovant Therapeutics

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Vice President, Regulatory Affairs and Quality

  • Apr 2023 - Present

• Vice President, Quality

  • Oct 2021 - Apr 2023

  Raleigh-Durham-Chapel Hill Area



Precision BioSciences, Inc.

• United States
• Biotechnology Research
• 100 - 200 Employee

• Vice President, Quality and Compliance

  • Sep 2019 - Oct 2021

  Raleigh-Durham, North Carolina Area

• Senior Director, Quality and Compliance

  • May 2018 - Sep 2019

  Raleigh-Durham, North Carolina Area



Liquidia Technologies

• South Africa

• Executive Director, Quality Assurance

  • Jan 2017 - May 2018

• Director, Quality Assurance

  • Apr 2015 - Dec 2017

  Responsible for all aspects of Quality Assurance.



Furiex Pharmaceuticals Inc.

• United States
• Pharmaceutical Manufacturing

• Director of Quality Assurance

  • Oct 2013 - Apr 2015

  Responsible for all aspects of GCP, GLP and GMP Quality Assurance in an outsourced environment. This includes Quality oversight of all vendors.



Advanced Liquid Logic

• United States
• Medical Device
• 1 - 100 Employee

• Director of Quality Assurance and Regulatory Affairs

  • Apr 2012 - Oct 2013

  Responsible for all aspects of Quality Assurance and Regulatory Affairs. This includes preparation and submission of required FDA filings and implementation of a robust Quality Management System.



Catalent Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manager, Quality Systems

  • Jun 2011 - Apr 2012

  Responsible for document and record control, metrics, internal / external / supplier audits, training and TrackWise administration.



Self Employed

• Real Estate
• 1 - 100 Employee

• Pharmaceutical Quality, Compliance and Validation Consultant

  • Mar 2011 - Jun 2011

  Provided consulting services to a variety of pharmaceutical, biotechnology and medical device clients. Areas of focus include Quality Systems, GXP Compliance and Validation.



Biogen Idec

• Associate Director, Global GXP Compliance

  • Aug 2008 - Jan 2011

  Managed a global department of twelve responsible for corporate documentation, global change control and oversight / continuous improvement of the Quality Management System. Ensured systems met internal customer needs. Managed budgets / resource allocation.

• Senior Manager, Global Quality Management / Corporate Quality Validation

  • Jul 2004 - Aug 2008

  Managed a global group for development, implementation and continuous improvement of validation and change control procedures and programs.

• Manager, Validation

  • Jun 2002 - Jun 2004

  Managed a group responsible for all equipment, cleaning and automation validation at the RTP facility. This included drug substance manufacturing, QC laboratories and warehouse space. Also responsible for collaborative improvement of validation systems and managing budgets / resource allocation.

• Quality Assurance Specialist II

  • Oct 2001 - Jun 2002

  Reviewed and approved completed validation protocols and engineering documents at the RTP facility.



Apex Bioscience

• United States
• Biotechnology Research

• Validation Engineer

  • Jun 1999 - Oct 2001

  Managed engineering and validation activities, as well as supervision of Quality Assurance and Documentation staff.



Phyton Biotech

• United States
• Biotechnology Research
• 1 - 100 Employee

• Validation Engineer

  • Jan 1998 - Jan 1999

  Performed a variety of engineering, validation and compliance tasks on a one year contract assignment during the facility start-up including completion of validation protocols on a variety of manufacturing and Quality Control laboratory equipment.



Unigene Laboratories, Inc.

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Production Associate

  • May 1996 - Dec 1997

• Production Associate

  • Feb 1995 - May 1996