What are the responsibilities and job description for the Quality Assurance Project Manager position at Intellectt Inc?
Overview
We are seeking an experienced Quality Control Project Manager to support a large‑scale advanced therapies manufacturing program. This role is focused on coordinating Quality Control (QC) operations across internal teams and multiple external partners, ensuring timelines, documentation, and deliverables remain on track.
This is not a hands‑on laboratory role. Instead, the Project Manager will drive visibility, accountability, and execution across complex QC workstreams in a fast‑paced, highly regulated environment.
Key Responsibilities
Coordinate QC activities across internal stakeholders and 3–4 external partners, including laboratories and contract manufacturing organizations (CMOs)
Track and manage timelines related to:
Sample lifecycle and testing progress
Deviations, investigations, and CAPAs
QC documentation (e.g., Certificates of Analysis, protocols, compliance records)
Proactively follow up with stakeholders to ensure milestones and deliverables are met
Identify risks, issues, and delays; escalate appropriately and drive resolution
Facilitate clear communication between QC teams, lab groups, and external partners
Provide regular status updates, reporting, and visibility to leadership
Support transition and knowledge transfer from an existing project manager, including ownership of active initiatives
What Makes This Role Unique
Strong emphasis on coordination and accountability, rather than execution
Opportunity to manage complex QC workstreams across a broad external manufacturing network
Exposure to advanced therapies manufacturing programs
High‑impact role supporting urgent and growing project demand
Qualifications
Experience in Quality Control, laboratory operations, or GMP‑regulated environments
Proven track record of managing timelines and driving project execution
Strong experience working with external partners, laboratories, or CMOs
Ability to be tactfully assertive and hold stakeholders accountable
Excellent organizational, communication, and follow‑up skills
Comfortable operating in fast‑paced, evolving project environments
Nice to Have
Experience supporting advanced therapies, cell therapy, or gene therapy programs
Familiarity with deviations, CAPAs, and QC investigations