Senior Manager Quality Control, Lab Operations
Core
Lead a team supporting the technical and operational lifecycle of highly automated QC laboratories, including new builds, fit-outs, technology implementation, and continuous capability upgrades.
Role type
Senior Manager, QC Lab Operations
Builds
Highly automated drug substance manufacturing QC laboratories and integrated technology portfolios
Domain
Life Sciences / Pharmaceutical Manufacturing / Quality Control
Required skills
People leadership, organizational design, workforce strategy, project portfolio management, GMP compliance, data integrity, regulatory inspection representation, change control, CAPA management, vendor strategy, capital project management
Preferred skills
None stated
Technologies
LIMS, CDS, automated manufacturing equipment
Responsibilities
Lead and develop a larger team, own organizational design and headcount planning; Lead integrated portfolio of lab builds and technology implementations; Ensure training compliance and site-wide skills strategy; Represent QC Lab Operations at executive forums; Act as senior escalation point for critical issues; Accountable for deliverable compliance with cGMP and data integrity requirements; Lead all aspects of change control, deviation, and CAPA performance; Serve as senior spokesperson in regulatory inspections and internal audits; Define function's performance metrics.
Seniority
Senior Manager, hands-on leadership