Quality Control Manager
Core
Plans, organizes, directs, and controls entire Laboratory activities to assure compliance with corporate policies and governmental regulations, acting as the official QC representative during FDA, DEA, and internal inspections.
Role type
Senior Quality Control Manager (Pharmaceutical Manufacturing)
Builds
Ensures plant compliance with analytical testing requirements and regulatory standards for raw materials, finished products, and microbiological testing.
Domain
Pharmaceutical manufacturing / Quality Assurance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Laboratory operations & compliance)
Required skills
Regulatory compliance (cGMP/FDA), Laboratory management, Analytical method validation, OOS/OOT investigation, Budget control, Resource planning, Team leadership, Project management
Preferred skills
Quality Management Systems (QMS) knowledge, Advanced project management, Cross-functional negotiation
Technologies
USP/EP Pharmacopeia standards, GMP documentation systems, Microsoft Office (Word, Excel, PowerPoint)
Responsibilities
Lead complex laboratory investigations including Out of Specification (OOS) and Out of Trend (OOT); Ensure laboratory activities comply with regional Pharmacopeia standards; Establish measurable improvement processes and metrics; Approve GMP related documentation such as SOPs, Change Controls, and Validation documents; Manage departmental budget controls and HR company policy; Actively participate in FDA and other regulatory inspections.
Seniority
Senior, hands-on IC with management responsibilities
