Sterility Assurance Program Lead — Senior Consultant

ProPharma Group; Kansas City (KS); On-site; USD 120,000 - 160,000; Full time

Job summary

ProPharma Group seeks a Program Lead/Sterility Assurance Review Senior Consultant to oversee a retrospective product review workstream in Kansas City, KS on site for a 2-3 month engagement. The role leads the review methodology, coordinates lot assessments, and delivers final reports to ensure regulatory alignment.

You will act as the primary client contact, provide technical oversight of sterility review activities, and guide the team to maintain scientific rigor and FDA remediation alignment.

Qualifications

• 10 years of experience in sterile/pharmaceutical environments.
• Proven ability to lead cross-functional review teams and projects.

Responsibilities

• Lead the sterility review team (2-3 people) and serve as the primary client contact.
• Develop and finalize the review protocol and assessment methodology.
• Coordinate execution of the retrospective review and deliverables.
• Provide technical oversight of the review process and secondary reviews of assessments.
• Review conclusions for consistency and scientific rationale; escalate key product-quality concerns as needed.
• Support preparation and finalization of interim and final reports; participate in governance meetings.

Skills

Sterile manufacturing

Sterility assurance

Product impact assessments

Aseptic processing

FDA remediation

Job description

ProPharma Group seeks a Program Lead/Sterility Assurance Review Senior Consultant to oversee a retrospective product review workstream in Kansas City, KS on site for a 2-3 month engagement. The role leads the review methodology, coordinates lot assessments, and delivers final reports to ensure regulatory alignment.

You will act as the primary client contact, provide technical oversight of sterility review activities, and guide the team to maintain scientific rigor and FDA remediation alignment.