Christopher Shea Email & Phone Number

Boston, MA, US

Cambridge, Massachusetts, US

Cambridge, Massachusetts, US

Arlington, Massachusetts, US

Reporting to the Vice President of Quality Operations, this position is accountable for the development, validation, and maintenance of automated, controlled systems used by Kala to perform the responsibilities required by FDA’s regulations for pharmaceutical virtual manufacturers. Owner of the Trackwise Quality Management System (EQMS) used by Quality.

Arlington, Massachusetts, US

Reporting to the Vice President of Quality Operations, this position is responsible for developing, supporting, and maintaining strategic alignment of controlled systems at Kala. Responsible for establishing a Quality Management System (QMS) to ensure compliance with FDA requirements (21 CFR Part 211, 21 CFR Part 11, and HIPAA) and ensuring systems are.

High level individual contributor role responsible for System Qualification/Validation/Management ensuring compliance of production and Quality systems to 21 CFR Part 11, Annex11, and Japanese eDocument regulations

Quality leadership role responsible for defining and implementing an efficient QA operating model to align with the company’s business goals and over a dozen Biotech/Pharmaceutical client’s compliance needs. Led the Project Management practice, mentoring team members on projects, as well as authoring critical documents for Validation Projects and.

Provided input and guidance to the Company's Managed Service team while also performing System Analyst backup role. Responsible for ensuring customer and partner satisfaction and provided monthly analytics to the executive team on customer and sales pipeline health.

Built successful customer base by acting as consultant to prospective new clients and grew existing client base 3%. Acted as single point of contact to customers as liaison for service, finance, and sales opportunities.