Quality Senior Manager
Core
Lead the Quality Function within Operations to ensure effective implementation of Quality Systems for drug and packaging materials, manufacturing, validation, and regulatory compliance.
Role type
Senior Manager, Quality Operations
Builds
Pharmaceutical and biologics products ensuring cGMP and regulatory compliance
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Quality Assurance, Quality Control, Regulatory Compliance (cGMP, FDA, EU), Budget Management, Team Leadership, Validation, Quality Engineering, Statistical Quality Systems, Laboratory Information Management
Preferred skills
Certified Quality Engineer, Master's Degree or PhD in Physical/Life Sciences/Pharmacy/Engineering, Experience in API/Fin Goods/Biologics/Device manufacturing
Technologies
Electronic document management systems, Laboratory information management systems
Responsibilities
Manage a team of quality professionals, Ensure product conformance with corporate and regulatory requirements, Develop and administer the annual operating budget, Provide regulatory and technical guidance to plant departments, Make quality decisions regarding facility design and product specifications
Seniority
Senior, hands-on IC with leadership responsibilities
