Director, Information Systems Management

Vertex Pharmaceuticals•Boston, MA

2d•Hybrid

About The Position

Provides strategic quality oversight across GxP computer systems and strategic direction to management of QA-owned systems in support of effective deployment of the Quality Management System (QMS). Coordinating strategic direction and leadership in delivery of operational support, consultation and oversight in assuring adherence with regulatory requirements for computer systems across GxP regulated environments, and adequacy of systems controls for assuring data integrity, and in support of excellence in quality. Driving strategic direction and oversight in the execution of QISM information management strategies, practices, capabilities, and performance in partnering across QA, functions, teams, and third parties for regulatory compliance, data integrity, and quality of GxP computer systems.

Requirements

Bachelor's degree in Pharmaceutical Science, Allied Health or a related field and 10 years of experience in the job offered or in a Director, Information Systems Management -related occupation.
Master’s degree in Pharmaceutical Science, Allied Health , or a related field and 8 years of experience in the job offered or in a Director, Information Systems Management -related occupation.
Demonstrable experience in coordinating strategic planning in quality system implementations and execution skills.
Demonstrable experience in designing, evolving and implementing Quality Management Systems including Quality Standards, Risk Assessments, Computer Systems Validation and Systems Lifecycle in a fit-for-purpose manner.
Demonstrable experience in driving progressive quality management in a regulated environment.
Demonstrable experience in managing individuals and teams with proven leadership capabilities within complex, matrixed organization.
Demonstrable experience in driving computerized systems quality and data integrity in a regulated environment.

Responsibilities

Provides strategic quality oversight across GxP computer systems.
Provides strategic direction to management of QA-owned systems in support of effective deployment of the Quality Management System (QMS).
Coordinates strategic direction and leadership in delivery of operational support, consultation and oversight in assuring adherence with regulatory requirements for computer systems across GxP regulated environments.
Ensures adequacy of systems controls for assuring data integrity, and in support of excellence in quality.
Drives strategic direction and oversight in the execution of QISM information management strategies, practices, capabilities, and performance in partnering across QA, functions, teams, and third parties for regulatory compliance, data integrity, and quality of GxP computer systems.