Experience

Morphic Therapeutic

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Associate Director Quality - Audit and Vendor Management

  • Aug 2021 - Present

  Remote position:-Responsible for global audit management and oversight of vendors supporting development and clinical study activities.-Develop and maintain audit universe and create/manage master audit schedule.-Approve vendor lists for GCP, GLP, GMP and GVP, and overall execution of the audit management of external vendors.-Liaise across groups to promote collaborations between the QM and relevant functional areas to effectively conduct a risk-based audit program. -Partner with the other functional departments to identify new vendors, or new services to be utilized from existing vendors, and assess the associated risk and potential audit requirements. -Participate in decisions to optimize risk-based audit tools, manage the audit/vendor management system and develop metrics for reporting to senior management.-Developed phase appropriate SOP roadmap and led implementation of over 20 SOPs effectively communicating cross functionally and providing project management expertise. -Support the testing of new Quality Management System (Audit and Supplier Management program) with implementation by end of year 2022.



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manager - Audit and Assurance (Retired)

  • Oct 2010 - Aug 2021



Malaria Consortium

• United Kingdom
• Non-profit Organizations
• 500 - 600 Employee

• Audit Manager (pro bono with NGO)

  • Jul 2017 - Feb 2018



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Manager / Associate Director

  • 1992 - 2010

• Analytical Chemist - New Product Development

  • Aug 1988 - Jul 1992