Quality Control Lab Operational Readiness
Core
Leading end-to-end operational readiness strategy, integrated planning, and execution for a new QC laboratory supporting biologics manufacturing and ADC supply.
Role type
Associate Director, Operational Readiness (Quality Control)
Builds
A new QC laboratory for high-potent biologics and Antibody Drug Conjugates (ADCs) at a biotech campus.
Domain
Biotechnology / Life Sciences / Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Integrated project management, cross-functional leadership, schedule governance, risk management, SOP development, sample management strategy, inventory management, stability program operations, regulatory compliance (cGMP, FDA, EMA, ICH), change control, root cause analysis
Preferred skills
Lean practices, digital enablement, continuous improvement
Technologies
LIMS, digital tools
Responsibilities
Lead development and governance of the QC laboratory operations readiness schedule; Define and lead document readiness strategy including SOPs and training materials; Lead design and implementation of end-to-end sample management operating model; Lead laboratory inventory management strategy for consumables and reagents; Provide operational leadership for stability program readiness; Ensure compliance with cGMP and regulatory requirements; Lead long-term laboratory operations model post-go-live.
Seniority
Senior, hands-on IC with strategic planning and cross-functional leadership