Director, Quality Assurance Operations
Core
Leading QA Operations to ensure cGMP compliance for clinical manufacturing of gamma delta T cell therapies and supporting regulatory submissions.
Role type
Director, Quality Assurance Operations
Builds
cGMP-compliant clinical manufacturing processes and quality systems for allogeneic gamma delta T cell therapies
Domain
Biotechnology / Cell Therapy / Clinical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, regulatory submissions, quality risk management, validation program management, deviation investigations, change control, raw material QA release, continuous improvement, cross-functional leadership
Preferred skills
cell therapy experience, Health Authority inspection experience
Technologies
LIMS, eQMS
Responsibilities
Ensure cGMP compliance for phase I/II/III investigational product manufacturing; lead lot disposition activities including batch record and stability testing review; review development activities in preparation for GMP; champion the Quality Risk Management Program; lead the phase-appropriate validation program; serve as team leader for quality investigations and change controls; partner with Facilities for equipment qualifications; manage cGxP training programs; represent the organization during third-party audits; provide oversight for the raw material program; develop and implement QA procedures and policies; support regulatory submissions of quality-related sections; drive continuous improvement initiatives
Seniority
Director, strategic management & team leadership
