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
BA or BS in a science related field (e.g., chemisty, physics, life sciences).
Minimum of 5 years of experience in quality management.
Familiarity with drug master files in US or other locations, particularly drug substance and API filings.
Experience in Technology Transfer, Scale up, and early phase clinical development.
Experience and/or understanding of nuclear technology.
Solid understanding of quality management and continuous process improvement principles including global cGMP requirements.
Previous supervisory experience.
Previous experience with direct interaction with regulatory agency representatives.
Laboratory experience with analytical instrumentation (e.g., HPLC, GC, gamma spectroscopy, ICP, UV-Vis) and associated software packages.
Additional Salary Information: Grade: GGS - 12
University Title: Manager Research Technical Services
Internal Number: 32188
About University of Missouri Research Reactor (MURR®)
For more than 50 years the faculty and staff of the University of Missouri Research Reactor (MURR®) have promoted ground breaking research and developed life-saving radiopharmaceuticals, providing benefits to people across the country and around the world. MURR is the highest-power university research reactor in the United States, operating at 10 megawatts, 6.5 days a week and 52 weeks a year. The MURR facility enables research across many disciplines – From investigating ancient cultures and how plants respond to their environment, to analyzing industrial materials and developing radiopharmaceuticals that have lifesaving clinical applications, the MURR facility is a reliable resource for researchers, scientists, engineers and students across the country.