Experience

CinCor Pharma, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Director, Quality Assurance

  • Feb 2022 - Present



T2 Biosystems

• United States
• Biotechnology
• 1 - 100 Employee

• Senior Director, Quality Management

  • May 2017 - Feb 2022



Fallschirm, LLC

• Director, Quality Compliance

  • Apr 2016 - May 2017



TARIS Biomedical, Inc

• Director, Quality

  • Apr 2010 - Mar 2016



Boston Scientific

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• GCP, Consultant

  • Apr 2009 - Sep 2009

  Providing GCP support for on-going CAPA projects, SOP development and multiple business improvement projects Providing GCP support for on-going CAPA projects, SOP development and multiple business improvement projects



Acusphere, Inc.

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Consultant

  • Nov 2008 - Feb 2009

  Prepared commercial facility and staff for FDA Pre-approval Inspection by conducting risk assessments of the quality system, facility and equipment validation, and analytical method validation. Managed the support staff during the conduct of the FDA Pre-approval Inspection. Prepared talking points for specific questions from the inspectors. Analyzed inspectors questions and comments to anticipate what documentation would be required for follow-up questions. Prepared commercial facility and staff for FDA Pre-approval Inspection by conducting risk assessments of the quality system, facility and equipment validation, and analytical method validation. Managed the support staff during the conduct of the FDA Pre-approval Inspection. Prepared talking points for specific questions from the inspectors. Analyzed inspectors questions and comments to anticipate what documentation would be required for follow-up questions.



EPIX Pharmaceuticals

• Biotechnology Research
• 1 - 100 Employee

• Senior Manager, Quality

  • Feb 2008 - Oct 2008

  Insured that clinical materials were manufactured to phase-appropriate federal and international quality standards by overseeing the day-to-day activities of contact manufacturers. Conducted GCP audits of Trial Master Files, Site Master Files, Contract Research Organizations and Central Laboratories. Conducted GMP audits in anticipation of regulatory pre-approval inspections Supported Regulatory Affairs activities for resubmitting the NDA application for gadofosveset trisodium, an… Show more Insured that clinical materials were manufactured to phase-appropriate federal and international quality standards by overseeing the day-to-day activities of contact manufacturers. Conducted GCP audits of Trial Master Files, Site Master Files, Contract Research Organizations and Central Laboratories. Conducted GMP audits in anticipation of regulatory pre-approval inspections Supported Regulatory Affairs activities for resubmitting the NDA application for gadofosveset trisodium, an injectable intravascular contrast agent. Implemented a new electronic document archive with a searchable database and oversaw the conversion of paper documents to electronic records. Coordinated the implementation of SOPs for the materials management team. Show less Insured that clinical materials were manufactured to phase-appropriate federal and international quality standards by overseeing the day-to-day activities of contact manufacturers. Conducted GCP audits of Trial Master Files, Site Master Files, Contract Research Organizations and Central Laboratories. Conducted GMP audits in anticipation of regulatory pre-approval inspections Supported Regulatory Affairs activities for resubmitting the NDA application for gadofosveset trisodium, an… Show more Insured that clinical materials were manufactured to phase-appropriate federal and international quality standards by overseeing the day-to-day activities of contact manufacturers. Conducted GCP audits of Trial Master Files, Site Master Files, Contract Research Organizations and Central Laboratories. Conducted GMP audits in anticipation of regulatory pre-approval inspections Supported Regulatory Affairs activities for resubmitting the NDA application for gadofosveset trisodium, an injectable intravascular contrast agent. Implemented a new electronic document archive with a searchable database and oversaw the conversion of paper documents to electronic records. Coordinated the implementation of SOPs for the materials management team. Show less



Sunovion Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Manager, Quality

  • 2004 - 2008

  Directed late stage commercialization Quality Assurance activities including oversight of process validation, component and product manufacturing, approving content of FDA regulatory filings, establishing internal quality systems, auditing of contractors and complaint investigation management. Managed the process validation for a new dosage size of levalbuterol tartrate, HFA and ensured that commercial supplies were ready for product launch. Coordinated commercial investigations… Show more Directed late stage commercialization Quality Assurance activities including oversight of process validation, component and product manufacturing, approving content of FDA regulatory filings, establishing internal quality systems, auditing of contractors and complaint investigation management. Managed the process validation for a new dosage size of levalbuterol tartrate, HFA and ensured that commercial supplies were ready for product launch. Coordinated commercial investigations and change control management requiring multiple disciplines. Restructured the annual product review system to support a growing product pipeline. Show less Directed late stage commercialization Quality Assurance activities including oversight of process validation, component and product manufacturing, approving content of FDA regulatory filings, establishing internal quality systems, auditing of contractors and complaint investigation management. Managed the process validation for a new dosage size of levalbuterol tartrate, HFA and ensured that commercial supplies were ready for product launch. Coordinated commercial investigations… Show more Directed late stage commercialization Quality Assurance activities including oversight of process validation, component and product manufacturing, approving content of FDA regulatory filings, establishing internal quality systems, auditing of contractors and complaint investigation management. Managed the process validation for a new dosage size of levalbuterol tartrate, HFA and ensured that commercial supplies were ready for product launch. Coordinated commercial investigations and change control management requiring multiple disciplines. Restructured the annual product review system to support a growing product pipeline. Show less



Alkermes

• Ireland
• Biotechnology Research
• 700 & Above Employee

• Quality Compliance Manager, Corporate

  • 1992 - 2004

  During my 12 years at Alkermes, I held several different quality roles with increasing responsibility and authority. Highlights: Created a comprehensive Quality Assurance program in twelve months for combination products produced by the Pulmonary Delivery Division which included expanding the Quality Assurance group from one employee to five. Supported the validation of new manufacturing site by revising the validation master plan, reviewing executed validation protocols, managing review… Show more During my 12 years at Alkermes, I held several different quality roles with increasing responsibility and authority. Highlights: Created a comprehensive Quality Assurance program in twelve months for combination products produced by the Pulmonary Delivery Division which included expanding the Quality Assurance group from one employee to five. Supported the validation of new manufacturing site by revising the validation master plan, reviewing executed validation protocols, managing review process for protocol deviations and managing the corporate change control personnel Developed an audit program based upon corporate policies, industry standards and quality standards. Supported several regulatory authority inspections by conducting internal and external audits, data reviews and preparing inspection participants. Trained four employees who successfully passed the ASQ Certified Quality Auditor Exam. Show less During my 12 years at Alkermes, I held several different quality roles with increasing responsibility and authority. Highlights: Created a comprehensive Quality Assurance program in twelve months for combination products produced by the Pulmonary Delivery Division which included expanding the Quality Assurance group from one employee to five. Supported the validation of new manufacturing site by revising the validation master plan, reviewing executed validation protocols, managing review… Show more During my 12 years at Alkermes, I held several different quality roles with increasing responsibility and authority. Highlights: Created a comprehensive Quality Assurance program in twelve months for combination products produced by the Pulmonary Delivery Division which included expanding the Quality Assurance group from one employee to five. Supported the validation of new manufacturing site by revising the validation master plan, reviewing executed validation protocols, managing review process for protocol deviations and managing the corporate change control personnel Developed an audit program based upon corporate policies, industry standards and quality standards. Supported several regulatory authority inspections by conducting internal and external audits, data reviews and preparing inspection participants. Trained four employees who successfully passed the ASQ Certified Quality Auditor Exam. Show less