Summary of Position

• Have responsibility for ensuring that all quality management functions are maintained according to GMP requirements
• Oversee GMP Quality Assurance, Quality Control, and Microbiology activities for multiple FDA-approved radiochemical products (drug substances)
• Develop, implement and monitor departmental objectives and schedules and set priorities and performance expectations for staff
• Ensure alignment of GMP quality program activities with MURR’s strategic priorities

Detailed Description of Duties

As part of MURR’s Products and Services Management Team, this position has responsibility for overall management of MURR’s Quality System functions: 

• Ensure regulatory compliance and quality of all marketed GMP products
• Manage QA, QC, Production, and Microbiology Leads to continuously improve procedures and tools to support quality deliverables
• Promote understanding and adherence to quality programs among internal and external stakeholders
• Manage GMP internal audit program
• Manage external GMP audits of suppliers, contract manufacturers, and contract testing laboratories
• Manage production batch record review and product release
• Lead response to emergent production and quality issues, including determination of product disposition
• Manage internal investigations to ensure complete and accurate documentation and appropriate corrective and preventive actions
• Identify and escalate compliance issues to Senior Management
• Review and approve documents as required, including SOPs, validations, and non-conformances
• Continuously review and improve quality system effectiveness and efficiency
• Work closely with production and regulatory affairs management to ensure continuous improvement measures are implemented consistently.
• Support activities for products in development including acting as a consultant to ensure quality is designed in to incoming processes and products
• Establish Quality/Technical Agreements with suppliers, contract manufacturers and testing labs
• Prepare Annual Product Reviews and assist with Management Reviews