Quality Control Project Manager, Advanced Therapies, New Manufacturing Facility

Description Hybrid 1 week onsite per month in Lebanon, IN

Our client seeks a Quality Control Project Manager to support Advanced Therapies external manufacturing programs. The role will coordinate QC operational activities, manage timelines and deliverables, and maintain clear communication across internal teams, testing laboratories, and external manufacturing partners. As manufacturing expands, this role will provide structured oversight of QC workstreams to ensure timely execution, progress visibility, and stakeholder alignment. The position reports to the Principal Scientist – QC Project Manager.

Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance. Rate: $65.00 to $75.00/hr. w2

Responsibilities

• Coordinate and manage Quality Control operational workstreams supporting commercial manufacturing programs.
• Develop, maintain, and communicate project timelines, milestones, and deliverables.
• Monitor progress against project plans and identify risks, issues, and potential delays.
• Partner with internal Quality Control subject matter experts and external stakeholders to ensure execution of critical activities.
• Facilitate cross-functional communication and alignment among laboratories, manufacturing partners, and project teams.
• Coordinate sample management activities with internal and external testing sites and track sample status through the testing lifecycle.
• Monitor testing progress and turnaround times and communicate updates to stakeholders.
• Track laboratory investigations from initiation through closure and maintain investigation logs and status reports.
• Coordinate communication between laboratories and project stakeholders and ensure timely follow-up on actions and deliverables.
• Support lifecycle management of laboratory documentation, including CC, testing protocols, COA, and COT.
• Track document creation, review, approval, and distribution activities and ensure alignment with GMP requirements and project timelines.
• Identify, document, and escalate quality issues, deviations, risks, and critical situations and support mitigation and resolution plans.
• Provide timely communication to management and assist with status summaries, metrics, and project reports.

Experience Requirements

• Bachelor’s degree in a scientific discipline or equivalent combination of education and industry experience.
• Experience working within Quality Control laboratories in regulated pharmaceutical environments.
• Experience managing deliverables and coordinating activities within cGMP environments.
• Understanding of pharmaceutical manufacturing processes and GMP quality systems.
• Working knowledge of data integrity principles and requirements, including ALCOA+.
• Project management experience with ability to manage timelines, milestones, and deliverables and build effective internal and external relationships.
• Strong organizational, communication, and coordination skills.
• Preferred: Experience in gene therapy.
• Preferred: Experience with external manufacturing organizations, contract laboratories, or CDMOs.

Education Requirements Bachelor’s degree in a scientific discipline or equivalent combination of education and industry experience.