Dotty Paquin

Manager Quality System and Compliance @Ironwood Pharmaceuticals

Boston, MA, US

Act as administrator for Solabs QMS; performing change risks assessments, managing system performance, and ensuring alignment with regulatory and internal compliance requirements.Coordinate with internal and external stakeholders to modify and maintain the eQMS (Solabs QM10) that includes modules for Document Management, Out-ofSpecification (OOS), Deviation, Change Control, Corrective and Preventative Actions (CAPA), Product Complaints, and Audits.Act as the Document Control Coordinator; enabling timely and accurate development, deployment, and maintenance of controlled documentation through the Document Change Control Process.Generate and communicate applicable system metrics and reports, fulfilling schedules and ad-hoc requests, for users, managers, and Quality Compliance Committee (QCC) or similar governance bodies.Identify, generate and deliver education, tools, and tips to support and enhance user acceptance. Train system users in the use of software-based processes, procedures and best practices.Provide general audit and regulatory inspection support as part of Ironwood’s Inspection Team. Additionally, support GxP Audits, Inspections, and Periodic System Reviews as a system SME and providing necessary Quality System reports to fulfill requests.Maintain current knowledge of and ensure all functional work team activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory, GxP requirements and related policies and procedures. Advocates for full legal compliance and ethical conduct in all business transactions.

Quinnipiac University

Bachelor of Science - BS

University of New Hampshire

Continuing Education

University of Phoenix

Master of Business Administration - MBA