Quality Assurance Project Manager - The Fountain Group

The Fountain Group.  We are a national staffing firm and are currently seeking a ­­­­­­­­Quality Assurance Project Manager for a prominent client of ours.  This position is in ­North Chicago, IL 60064. Details for the position are as follows:

Job Description:

• $44 - $47/hour, full-time, Hybrid Schedule.
• This individual will work in the Global Quality System & Strategic Transformation organization supporting global projects and initiatives.
• Activities include all aspects of project management for Drug Shortage Prevention Plans (DSPP), creation of deliverables, working with stakeholders and driving technical enhancements.
• The individual will directly work with the Global Quality Risk Management team and be responsible for establishing and maintaining records.
• DSPP work involves active collaboration with a cross-functional team in manufacturing sites, external manufacturing, regulatory, supply chain, product quality, compliance, and other global functions.
• This global function includes monitoring, tracking, and supporting various efforts and initiatives in the Quality System.

Responsibilities:

• Lead meetings to facilitate and/or support the DSPP Project.
• Actively collaborate with a cross-functional team to complete project milestones and DSPPs per established timeline.
• Assist the functional areas on completing the DSPP risk factors and input in the DSPP.
• QA review of DSPP content in compliance with established governing documents.
• Oversee, monitor, and track key deliverables associated with DSPP Implementation Project Metrics and related initiatives.
• Support other DSPP Project deliverables or initiatives as requested.

Qualifications:

• Bachelor's degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area.
• Minimum of 5 years of experience in Quality Assurance and/or Quality System. Risk Management, supply chain, compliance and drug shortages experience preferred.
• Lead meetings with technical professionals and experience in leading cross-functional teams with a results-orientated approach.
• Preferred: Knowledge of regulatory documents such as ICH, US / EU and other key GMP regulations.
• Skills: Result-oriented, strong oral and written communication skills, excellent interpersonal skills, initiative, attention to details, time management in a fast-paced environment, teamwork, problem solving and project management.
• Computer system skills including Microsoft Office; proficient in Power Point and Excel.