Purpose
We are seeking an experienced quality professional with a background in information delivery to support our team's business objectives.
This role requires a deep understanding of Pharmaceutical Quality Systems, data validation, and verification to drive key deliverables.
Responsibilities
* Support the delivery of a Quality Management Review (QMR) project
* Enable information delivery across all business units using Power BI or other data reporting and visualization tools as required
* Support data validation and verification activities, proactively identify data integrity issues, and collaborate on corrective actions
* Gather information from necessary business partners to create and monitor Quality Systems metrics in compliance with internal and external requirements
* Assist in developing systems and processes to ensure information delivery across functions 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
* E nsure compliance with Gx P guidelines and regulatory requirements in all documentation and quality systems activities
* Maintain thorough and accurate Gx P 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
Requirements
* 5+ years of experience in a Quality Systems role within the pharmaceutical industry, working to Gx Ps
* Bachelors degree(or equivalent) in a technical or life sciences discipline
* Knowledge of requirements for a Quality Management System
* Experience in authoring, reviewing, and maintaining Gx P 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 Gx P 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
Estimated salary: $90,000 - $120,000 per year