Senior Manager, Quality
Core
Lead the Quality Function within Operations to ensure effective implementation of Quality Systems, covering Incoming QA, Manufacturing QA, Validation, Quality Engineering, and Regulatory Compliance for a high-volume, complex pharmaceutical plant.
Role type
Senior Manager, Quality Operations
Builds
Pharmaceutical products (API, Fin Goods, Biologics, Packaging, Devices) ensuring cGMP and regulatory compliance
Domain
Pharmaceutical Manufacturing / Biologics / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Quality Oversight & Compliance)
Required skills
Quality Assurance, Quality Control, Validation, Regulatory Compliance (cGMP, FDA, EU), Budget Management, Team Leadership, Statistical Quality Systems, Electronic Document Management, Laboratory Information Management
Preferred skills
Certified Quality Engineer, Master's Degree or PhD in Physical/Life Sciences/Pharmacy/Engineering, Experience in R&D
Technologies
Electronic document management systems, Laboratory information management systems
Responsibilities
Manage a team of quality professionals and the annual operating budget for the Quality Unit; Ensure product manufacturing conforms to corporate Quality requirements and regulatory standards; Provide regulatory and technical guidance to all plant departments; Make quality decisions regarding facility design, laboratory controls, and product specifications; Communicate with executive leadership on Quality Management Reviews and initiatives.
Seniority
Senior, hands-on IC with leadership responsibilities
