Senior Quality Manager
Core
Manage coordination of Chemistry and Microbiology Laboratory activities to ensure product quality, performance, safety, and regulatory conformance.
Role type
Senior Quality Manager (Laboratory Operations)
Builds
Pharmaceutical/medical device products
Domain
Healthcare / Life Sciences / Manufacturing
Required skills
Regulatory compliance (cGMP), Laboratory management, Team leadership, Budget management, Corrective and preventative action planning, Inventory management, SOP implementation, Risk assessment
Preferred skills
Continuous improvement methodologies, Supplier quality assessment, Regulatory inspection interface
Technologies
Laboratory Information Management Systems (LIMS), 6S principles
Responsibilities
Manage chemistry and microbiology laboratory operations and process validation; Interface with regulators during inspections; Develop and manage departmental budget; Coach, train, and develop Quality Control staff; Investigate non-conformances and implement corrective actions; Maintain laboratory safety and facility standards.
Seniority
Senior, hands-on IC with management responsibilities