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

Apply

Vacancy posted 3 days ago

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