Sterility Assurance Program Lead – Senior Consultant

ProPharma Group; New York (NY); On-site; USD 140,000 - 190,000; Full time

Job summary

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.

The position requires extensive expertise in sterility assurance, aseptic processing, and regulatory remediation, with a proven ability to lead technical teams

Qualifications

• 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.

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.

Skills

Sterility assurance

Team leadership

Regulatory remediation

Client communication

Job description

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.

The position requires extensive expertise in sterility assurance, aseptic processing, and regulatory remediation, with a proven ability to lead technical teams