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Theresa Sheehan

Senior Director, Quality Assurance and Compliance at Nexstone Immunology

Theresa Sheehan has extensive experience in quality assurance and compliance within the pharmaceutical industry. Theresa is currently working as the Senior Director of Quality Assurance and Compliance at Nexstone Immunology since April 2022. Prior to this, they held the position of Director of GCP-Quality at Venatorx Pharmaceuticals, Inc. from September 2019 to June 2022, where they were responsible for designing and maintaining GCP compliance programs.

From June 2017 to August 2019, Theresa worked as the Director of R&D Quality Assurance at ACADIA Pharmaceuticals Inc. During this time, they provided input to R&D quality assurance activities and conducted internal and external audits within GCP, GLP, and GVP regulations. Theresa also served as the R&D QA Lead for various programs and participated in a Veeva Vault QMS Audit Management Development Project.

Before joining ACADIA Pharmaceuticals, Theresa worked as an Associate Director of Quality Assurance at PRA Health Sciences from January 2016 to June 2017. Their role involved quality assurance responsibilities within the company.

From 2006 to 2015, Theresa had a series of roles at Shire. Theresa served as an Associate Director of R&D QA & Compliance, Safety & International Lead from 2014 to 2015, where they managed auditing, inspection, and compliance strategies related to safety and risk management activities. Prior to this, they held the position of Associate Director of R&D QA & Compliance from 2012 to 2014, where they developed and implemented GCP auditing/inspection strategies. Theresa also worked as the R&D QA Manager from 2006 to 2012, overseeing various quality assurance responsibilities and managing contract auditors.

At Wyeth, Theresa served as the GCP Audit Manager from 2005 to 2006. Their role involved conducting GCP audits for vaccines programs and assessing compliance with regulations and industry standards.

Theresa began their career at Merck in 1999, where they worked as a Worldwide Clinical Quality Assurance Auditor. Their responsibilities included planning and executing site audits for clinical trials and ensuring compliance with Merck policies, regulations, and Good Clinical Practices.

Overall, Theresa Sheehan's work experience demonstrates their expertise in quality assurance, compliance, and auditing within the pharmaceutical industry.

Theresa Sheehan has a Bachelor of Science (BS) degree in Biology/Pre-Med from Saint Joseph's University. The exact timeline of their education is not specified. Additionally, they have obtained certifications in Clinical Safety and Pharmacovigilance from the Drug Information Association (DIA), as well as a Women in Leadership certification from Progressive Women's Leadership. The obtained dates for these certifications are not provided.

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Timeline

  • Senior Director, Quality Assurance and Compliance

    April, 2022 - present