QC Project Manager

Must have:

QC PM experience with 3-4 external CMO's

Tactful ability to manage external partners

Sample tracking, documentation, tracking deviations from inception to completion (not doing them, just tracking)

Job description

Overview

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 work streams, 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