Senior Director, Quality Assurance Avid Radiopharmaceuticals
Reports To: President and CEO
This position is responsible for developing and carrying out Avid?s quality assurance and compliance programs in support of medical imaging drug development and of commercial manufacturing (USA and International). The individual works closely with other R&D management of the company to define the appropriate QA and compliance goals and the strategies to achieve these goals. The individual manages a department of 4-5 professional QA staff. He/she works closely with the Corporate QA function within Eli Lilly to assure alignment of major goals and responsibilities for commercial phase QA product support. This position works with the R&D line functions to implement corrective and preventative actions systems and processes which enhance the quality of Avid work product, as well as meeting compliance standards under applicable cGMP, GCP, and GLP regulations and guidelines.
?with input from Avid R&D functional leaders and Lilly Corporate QA management, establishes QA strategic plans in support of R&D and commercial product quality assurance requirements for medical imaging drugs.
?works closely with management of chemical development, clinical development, preclinical development, manufacturing and quality control personnel at Avid while defining the scope of QA responsibilities and staffing requirements.
?collaborates with chemical development, manufacturing and quality control functions in the appropriate implementation of the quality assurance requirements of PET Drug cGMPs as defined in 21CFR Part 212 and associated guidances
?develops key QA metrics to communicate progress and issue resolution to Avid senior management and Lilly corporate QA groups
?manages and develops a group of QA professionals who are collectively responsible for carrying out the QA mission and responsibilities, including:
oassurance that the proper Standard Operating Procedures are in place for the critical drug development activities of the company and our external CRO or CMO partners.
ocoordination of periodic Quality Management Reviews and trend analysis of drug product manufacturing,
oreview and audit of internal department GCP, GMP and/or GLP compliance
oauthoring and implementation of QA SOPs
oplanning and conducting periodic compliance training on GLP, GMP and GCP regulations.
omanaging and coordinating regulatory inspections of the company and (for the company?s products) its CROs and CMOs
oworks closely with Corporate QA and Avid R&D functional leaders to develop and manage the required quality agreements with our CMOs or CROs
oacts as the company?s primary interface for communication with Regulatory agency field inspectors
?An advanced degree (e.g. MS/PhD) in a scientific discipline relevant to drug discovery and development.
?10-15+ years of quality assurance experience in a corporate drug development organization.
?expertise and experience in a CMC QA role as well as familiarity with Clinical QA requirements and responsibilities.
?A high level of familiarity and understanding of FDA regulations and guidelines.
?Several years experience in medical imaging drug development or parenteral therapeutic drug development is strongly preferred.
?Excellent working knowledge of applicable regulations, such as GLP, GMP and GCP, and related EU regulations is required.
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