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Our mid-sized, growing pharmaceutical client is seeking a Global Quality Solutions Representative consultant. This position reports to the Associate Director of Global Quality.
General Duties / Expectations of Role:
- Analyze and translate business requirements into system configurations within TrackWise Digital to ensure compliance and meet user needs.
- Lead meetings with Quality teams to educate, align, and implement enhancements across global sites.
- Act as the primary support contact for QMS process inquiries and provide front-line business support.
- Assist in user acceptance testing (UAT), including system verification and documentation review (URS, FRS, workflows).
- Develop training materials and conduct sessions for new system enhancements.
- Manage user access to QMS and maintain data integrity through standardized data practices and master data management.
- Partner with Global Quality stakeholders to define and implement digital solutions that streamline processes.
- Support innovation and risk management projects relevant to Global Quality Operations.
- Lead dictionary maintenance and data quality improvement initiatives.
- Collaborate with IT to troubleshoot and resolve QMS-related issues.
Qualifications
- A minimum of 3 years of Pharma Quality-related processes and QMS systems experience is required (TrackWise Digital preferred).
- Knowledge of Pharma Quality Standards
- Advanced analytical skills and a general understanding of the drug development and regulatory process are required.
- Knowledge of GxP areas
- Knowledge of Computer System Validation
- Experience with software applications that will be regularly used (in particular: Excel, MS Project, SharePoint, PowerPoint, and MS Teams).
Term & Start
- 12+ -month contract – option to extend
- Start Date: 2 weeks from the offer
- 2 Video Interviews
- Remote Opportunity –potential travel to NJ – prefer East Coast
- Benefits included (Medical, Dental, Vision, 401k)
Seniority level
Seniority level
Associate
Employment type
Employment type
Contract
Job function
Job function
Quality Assurance, Science, and OtherIndustries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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Inferred from the description for this job
Medical insurance
Vision insurance
401(k)
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