Ken Obrien

Experience

1. Senior Director, Pqm

   4G Clinical

   Jul 2023 — Present · Wellesley, MA, US

   The Role and Responsibilities of the Senior Director, PQM include: • Support of the Delivery team to ensure compliance of procedures and required deliverables in support of industry regulations. • Mentoring and training the PQM/Quality in the internal audits process. • Supporting and/or hosting client audits and regulatory inspections. • Providing the necessary leadership to ensure continuous improvement and applicability of 4G Clinical procedures and overall quality system. • Facilitating and management of quality system documentation periodic reviews. • Management of the supplier qualification and vendor audit program. • Maintaining awareness of regulatory actions locally, and globally, including legislation, regulatory authority formal opinion and publicly available inspection findings, and evaluate current procedures and quality system documentation for conformity through auditing. • Providing guidance and direction 4G Clinical staff with respect to regulatory compliance and industry best practices, and expectations and requirements of regulatory agencies.

Education

• Northeastern University

  Bachelor of Science (B.S.), Engineering Technology

  1986 — 1993