QC Project Manager

We are seeking a Quality Control Project Manager to support a large-scale advanced therapies manufacturing program. This role is focused on coordinating QC operations across internal teams and external partners ensuring timelines are met and critical activities remain on track.

This is not a hands-on testing role - instead the PM will drive visibility accountability and execution across complex QC workstreams including labs and external manufacturing partners.

Key Responsibilities

Coordinate QC activities across internal teams and 3 4 external partners (labs/CMOs)

Track and drive timelines for:

• Sample lifecycle and testing progress
• Deviations investigations and CAPAs
• QC documentation (COAs protocols compliance docs)
• Proactively follow up with stakeholders to ensure deliverables stay on track
• Identify risks issues and delays - and escalate appropriately
• Facilitate communication between QC lab teams and external partners
• Provide clear reporting and status visibility to leadership
• Support transition from current PM including knowledge transfer on active projects

What Makes This Role Unique

• Heavy emphasis on coordination vs. execution - you are driving the people who own the work not doing the work yourself
• Requires a tactfully assertive PM who can hold stakeholders accountable in a complex environment
• Exposure to advanced therapies and external manufacturing networks

Qualifications

• Experience in QC / laboratory / GMP environments
• Proven track record of managing timelines and driving project execution
• Strong experience working with external partners labs or CMOs
• Ability to manage multiple stakeholders and competing priorities
• Comfortable operating in fast-paced evolving project environments

Nice to Have:

• Experience in advanced therapies or gene therapy
• Experience with deviations CAPAs or QC investigations