Quality Record Investigation Lead Consultant

For the past 25 years, Pro Pharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organisations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. Pro Pharma 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, Pro Pharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programmes.

Client is seeking support to review, investigate, document, and close low-risk non-conformance and batch-related records within a six-week timeframe at their facility in Chicago, IL. All work will be conducted on-site for this project.

Consultant should have strong investigation, documentation, and batch record review/closure experience and be comfortable working independently within the client environment. This consultant will 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

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