Responsible for providing strategic and operational expertise to drive the management (planning, execution and follow-up of GCP Quality governance forums, councils and committees.
Serves as a liaison and SME for teams on the quality governance process and leads teams in planning and preparation for governance interactions.
Manages the development and oversight of Metrics generation to support compliance and impact/trend analysis across governance reviews.
Uses process experience and expertise to implement process workflow improvements and efficiencies and improvements in the process and documentation.
Oversees quality governance tools, tracking and mechanisms.
Facilitates and oversees the annual governance charter review process.

Have a robust understanding of GCP regulatory requirements and the Quality Management System (QMS).
Will be able to engage directly with various business representatives, business process owners, and leadership teams to assist with the adoption of consistent data privacy practices.
Will require pharmaceutical industry acumen.
Will be an effective communicator, demonstrate domain competency with respect to data privacy, and be familiar with operationalizing global or regional processes.
Will demonstrates strong analytical and critical thinking abilities, with a track record of identifying and resolving issues effectively.
Bachelor's Degree or equivalent experience a must.
5+years of related pharmaceutical and/or quality experience.

GCP Quality Governance Operations Lead – Senior Manager

Key skills