Quality Record Investigation Lead Consultant

About the role

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Responsibilities

• Review, investigate, document, and close low-risk non-conformance and batch-related records within a six-week timeframe at the client's facility in Chicago, IL (on-site).
• Possess strong investigation, documentation, and batch record review/closure experience; work independently within the client environment.
• Assume responsibility for overall execution, milestone management, and delivery performance.
• Primary client interface.
• Project management and KPI tracking.
• Weekly status reporting.
• Risk and issue escalation.
• Team oversight and productivity management.
• Support execution of exception and non-conformance investigations and closures as needed.