Purpose
We are seeking an experienced quality professional with an information delivery background to join our team. This role requires a strong understanding of Pharmaceutical Quality Systems, data validation and data verification to support key business deliverables.

Responsibilities

Support the delivery of a Quality Management Review (QMR) project
Support Information delivery across all business units using Power BI or other Data reporting and visualizations tools as required.
Support data validation and data verification activities, proactively identify data integrity issues and support corrective actions.
Gather information from necessary business partners to create and monitor of Quality Systems metrics in compliance with internal and external requirements.
Assist in the development of appropriate systems and processes to ensure delivery of information across function to support enhanced performance culture.
Collaborate with stakeholders to identify and support value-added improvements and Key Performance Indicators (KPIs) to the QMR.
Support procedural documentation and working practice document creation, update, and execution.
Ensure compliance with GxP (Good Practice) guidelines and regulatory requirements in all documentation and quality systems activities.
Maintain thorough and accurate GxP documentation to support compliance and inspection readiness.
Triage report requests/issues related to QMR via our ticketing system.
Provide forward thinking innovative solutions and identify opportunities to add value to the teams’ deliverables.
Other duties as required to support the growing Quality organization.

Requirements

5+ years of experience in a Quality Systems role within the pharmaceutical industry and working to GxPs.
Bachelor’s degree (or equivalent) in a technical or life sciences discipline
Knowledge of requirements for a Quality Management System
Experience in authoring, reviewing, and maintaining GxP documentation to ensure regulatory compliance
Direct experience and comprehension of systems supporting pharmaceutical manufacturing, IT infrastructure, and/or laboratory operations.
Prior experience in project leadership within a matrix environment.
Business engagement skills, with the ability to partner with both technical and non-technical roles
Able to prioritize and manage workload and manage shifting priorities based on criticality to ensure commitments are met.
Ability to work to tight deadlines
Strong understanding of GxP guidelines and compliance requirements.
Experience working in data warehouse building and administration
Analytical problem-solving skills applied to issue identification and resolution.
Integrating diverse perspectives to add value to the achievement of team goals and timely decision-making.
Project management skills combined with a sense of urgency and a proven history of producing quality deliverables.
Experience with quality management system software such as, Veeva,
Experience in system validation