Manager / Sr. Manager, Quality Assurance, Commercial QA
Core
Ensuring compliance with quality objectives and regulatory requirements for pharmaceutical products, including manufacturing, distribution, and third-party logistics.
Role type
Senior IC Quality Assurance Manager (Commercial QA)
Builds
High-quality pharmaceutical products and compliant quality management systems
Domain
Pharmaceutical industry + Quality Assurance/Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GQP/GMP/GDP knowledge, PMD Act knowledge, QA principles, Change Control management, Deviation Management, CAPA leadership, inspection coordination, new product start-up support, strategic quality oversight, risk-based decision-making
Preferred skills
Computer System Validation (CSV), Six Sigma/DMAIC, Risk Management tools (HACCP/FMEA), Project Management for launches/transfers, Biologics/Cell Therapy experience
Technologies
Electronic Document Management Systems, GXP applications
Responsibilities
Implement and maintain quality programs and processes, manage training department, review manufacturing and quality control data, lead investigations and CAPA, coordinate GMP inspections, ensure quality systems across contracted organizations, lead consistency checks between filings and operations
Seniority
Senior, hands-on IC with strategic oversight
