QP Quality Lead Pilot Plant
Core
Provide strategic quality leadership and Qualified Person (QP) oversight for the TRD GDPD Pilot Plant, ensuring compliance with global regulatory requirements for drug device combination products.
Role type
Qualified Person (QP) Quality Lead
Builds
Pilot Plant operations, including assembly, testing, storage, and technical release of drug device combination products.
Domain
Pharmaceutical/Medical Device Manufacturing (GxP, cGMP, GDP)
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Qualified Person (QP) certification, GxP compliance, regulatory inspection readiness, Quality Management System (QMS) management, deviation/OOS investigation, change control, risk assessment, batch release, validation/qualification principles, data integrity, drug-device combination product knowledge
Preferred skills
Clinical supply manufacturing experience, drug-device combination product expertise
Technologies
GxP frameworks, FDA 21 CFR Part 4, FDA 21 CFR Part 820/QMSR, EU MDR 2017/745, ISO 13485, ISO 14971
Responsibilities
Serve as Qualified Person for Pilot Plant operations, provide independent quality oversight for manufacturing/testing/warehousing/release, act as final quality decision maker, support health authority inspections and audits, coach and mentor quality associates
Seniority
Senior, strategic leadership & hands-on QP oversight
