Global Quality Solutions Representative 12-month Contract Hybrid in Princeton, NJ
Responsibilities
Support the optimization of quality systems by applying a process-centric approach to assess workflows, identify inefficiencies, and implement process improvements.
Partner with stakeholders to evaluate system enhancement needs, align improvements with business objectives, and support prioritization of initiatives.
Collect, analyze, and translate business requirements into system configurations within a Quality Management System (QMS) to meet user and compliance requirements.
Support the evaluation, testing, and implementation of AI capabilities within quality systems.
Facilitate meetings across Quality teams to communicate QMS process enhancements and gain alignment on new system configurations.
Provide frontline business support for QMS process requirements.
Support User Acceptance Testing (UAT) activities, including verification of system configurations.
Build partnerships with Quality teams and cross-functional stakeholders to support QMS initiatives.
Support user access management for the Quality Management System.
Assist with innovation projects related to Quality Operations and risk management.
Review validation documentation (e.g., URS, FRS, workflow diagrams) for accuracy during system enhancement releases.
Develop training materials for quality system enhancements as needed.
Define and implement data standards to support reporting, analytics, and system integrations.
Lead initiatives to improve data quality and maintain master data management practices.
Collaborate with Quality and cross-functional teams to develop digital solutions that optimize and streamline processes.
Partner with IT to resolve ongoing Quality Management System user issues.
Qualifications
Bachelor’s degree, preferably in a scientific discipline.
3–4 years of experience with pharmaceutical quality processes and Quality Management Systems.
Knowledge of pharmaceutical quality standards, TrackWise Digital, and Computer System Validation.
Understanding of GxP requirements and the drug development and regulatory process.
Experience with Computer System Validation.
Ability to influence stakeholders across multiple functions.
Strong partnership and collaboration skills in a matrixed, multicultural environment.
Advanced analytical and problem-solving skills.
Excellent written and verbal communication skills.
Proficiency with TrackWise, Microsoft Excel, SharePoint, PowerPoint, and Microsoft Teams.