Program Lead/Sterility Assurance Review 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

## Program Lead/Sterility Assurance Review Senior ConsultantApply: United States: Full time: Posted Yesterday: JR 10785For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma 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, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.**Location:** Kansas City, KS (onsite)**Duration:** 2-3 months **Scope:**Position will act as the overall lead for the retrospective product review workstream. Responsible for development of the review methodology, technical oversight of lot assessments, product impact evaluations, client communication, and final report review and approval. Duties include:* Lead the sterility review team (2-3 people)* Serve as the primary client point of contact and overall workstream lead.* Develop and finalize the review protocol and assessment methodology.* Coordinate execution of the retrospective review and associated deliverables.* Provide technical oversight of the review process.* Perform secondary review of lot assessments and product impact assessments.* Review technical conclusions for consistency and scientific rationale.* Facilitate escalation of significant product-quality concerns.* Support preparation and finalization of interim reports and final deliverables.* Participate in project governance meetings and status updates. **Years of Experience:** 10 years**Key Experience Required:** Sterile manufacturing, sterility assurance, product impact assessments, aseptic processing, FDA remediation