Program Lead/Sterility Assurance Review Senior Consultant
ProPharma Group
ProPharma Group seeks a Program Lead/Sterility Assurance Review Senior Consultant to direct a retrospective product review workstream for a pharmaceutical client. The role involves leading a small team, developing review methodology, overseeing lot assessments, and managing client communication over a 2-3 month engagement in Kansas City. Responsibilities Lead and direct a team of 2-3 sterility review specialists Develop and finalize the retrospective review protocol and assessment methodology Serve as primary client contact and overall workstream lead Perform secondary review of lot assessments and product impact evaluations Review technical conclusions for scientific consistency and support report finalization Requirements 10+ years of experience in sterile manufacturing and quality assurance Demonstrated expertise in sterility assurance and aseptic processing Experience with product impact assessments and regulatory remediation Proven ability to lead technical teams and manage complex projects Strong client communication and stakeholder management skills #J-18808-Ljbffr
Vacancy posted 2 days ago
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