Sr. Manager, Quality
Core
End-to-end Quality Assurance (QA) and Quality Control (QC) oversight for a plasmid DNA (pDNA) manufacturing facility, ensuring GMP compliance and regulatory readiness from commissioning to commercial production.
Role type
Senior Manager, Quality (Biologics Manufacturing)
Builds
GMP-compliant plasmid DNA manufacturing operations and quality systems for advanced therapies.
Domain
Biopharmaceuticals / Gene Therapy / Plasmid DNA Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, biologics manufacturing processes, plasmid DNA expertise, deviation/CAPA management, regulatory inspection readiness, team leadership, risk management (ICH Q9), analytical testing oversight
Preferred skills
LIMS/MasterControl/TrackWise proficiency, aseptic/non-aseptic operations, method transfer/qualification, contamination control, segregation requirements
Technologies
Microsoft Office, LIMS, MasterControl, TrackWise
Responsibilities
Lead GMP readiness and quality oversight during facility design, commissioning, and startup; Develop and maintain GMP-compliant Quality Systems including deviations, CAPA, and change control; Serve as QA lead for plasmid manufacturing operations overseeing batch execution and investigations; Oversee QC activities ensuring GMP-compliant laboratories and testing programs; Lead inspection readiness activities and support regulatory inspections; Build and develop a high-performing QA/QC team; Partner cross-functionally to resolve quality issues and drive continuous improvement
Seniority
Senior, hands-on leadership with direct management experience
