Sterility Assurance Lead - Retrospective Review Consultant

PPG US ProPharma Group, LLC; Nevada (IA); On-site; USD 166,000 - 240,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

ProPharma in Kansas City, KS is seeking a senior reviewer lead to oversee the retrospective sterility review workstream for a 2-3 month engagement. You will develop the review protocol, provide technical oversight of lot assessments, and communicate with the client to ensure timely delivery.

The role requires 10 years of sterile manufacturing experience, aseptic processing, and FDA remediation expertise. You will lead a small team, review technical conclusions, and contribute to final

Qualifications

• 10 years of experience in sterile manufacturing and related areas.
• Proven leadership of sterile review teams and client communication.
• Experience coordinating retrospective reviews and technical oversight.

Responsibilities

• Lead the sterility review team (2-3 people) and be 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 final conclusions.
• Escalate significant product-quality concerns as needed.
• Support interim and final deliverables and participate in governance meetings.

Skills

Sterile manufacturing

Sterility assurance

Product impact assessments

Aseptic processing

FDA remediation

Job description

ProPharma in Kansas City, KS is seeking a senior reviewer lead to oversee the retrospective sterility review workstream for a 2-3 month engagement. You will develop the review protocol, provide technical oversight of lot assessments, and communicate with the client to ensure timely delivery.

The role requires 10 years of sterile manufacturing experience, aseptic processing, and FDA remediation expertise. You will lead a small team, review technical conclusions, and contribute to final