Sr. Director - Quality Assurance - Radiopharmaceutical External Manufacturing

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Sr. Director - Quality Assurance - Radiopharmaceutical External Manufacturing leads quality oversight and strategy for a global network of radiopharmaceutical contract manufacturers, ensuring phase-appropriate qualification, regulatory readiness, and continuous improvement from Phase 1 through commercial supply. Works with R&D, CMC, Global External Manufacturing, Lilly Affiliates, leadership, and project teams to plan and execute these responsibilities. Interfaces with external trade and pharmaceutical associations to support the evolving Radiopharmaceutical regulatory landscape and the global delivery of products.

Manages a group of QA professionals responsible for establishing the quality oversight strategy and maintaining CDMO manufacturing quality across development and commercial stages.

• With input from R&D functional leaders and Lilly Corporate QA management, establish QA strategic plans and annual objectives in support of R&D and commercial product quality assurance requirements for contract manufactured Radiopharmaceutical PET imaging and Radioligand therapeutic drug products.
• Design and maintain phase appropriate third-party quality oversight strategies for various business models, third party capabilities, and measured performance/risks for the supply of Lilly compounds, out-licensing, and purchase of non-Lilly products
• Ensure the planning and collaboration with Global Quality Auditing to evaluate and maintain third party manufacturers and define and maintain quality oversight responsibilities with Lilly Affiliates via internal quality agreements for critical to quality event management
• Lead engagement with a global network of external partners and, in collaboration with Global External Manufacturing, assure CMO performance meets quality agreement arrangements and global standards.
• Lead functional area inspection readiness strategies and assessments alongside central Quality Systems and impacted business partners. Develop and manage key functional area and CMO performance metrics to assure Lilly is meeting its sponsor oversight responsibilities and CMO risks are effectively identified and managed.
• Assure periodic Quality Management Reviews and trend analysis of external manufacturing activities are completed per global standards, communicated to management, and risk based continuous improvement solutions are identified to manage emerging trends, site level performance, resourcing strategies, and support business objectives
• Assure sponsor QA support for third party regulatory inspections. Lead interactions with regulatory agencies regarding external manufacturing activities.
• Assure functional area and staff are trained and experienced to successfully meet responsibilities and objectives. Drive staff career planning and development.
• Create and maintain an annual budget
• Engage with external trade associations to network and influence the Radiopharmaceutical regulatory landscape for the development and manufacturing of radiopharmaceuticals
• Manage and develop a group of QA professionals who are collectively responsible for carrying out the QA mission and responsibilities, including:
  • Qualification and oversight of third-party manufacturers
  • Defining an adequate functional area quality system and continuously improving governing procedures and integrated global quality standards
  • Authoring and/or support Radiopharmaceutical global standards and integration of unique radiopharmaceutical features in collaboration Global Quality Systems
  • Identifying annual quality plan initiatives and required GMP self-inspections to ensure the areas of responsibility remain in a state of control and compliance.

• Required:
  
  Bachelors degree discipline relevant to drug discovery and development (i.e. Life Sciences) or relevant to pharmaceutical manufacturing
• Required:
  
  10+ years of quality assurance experience in drug development and novel commercially manufactured therapeutic agents.
• Required:
  
  Expertise in establishing quality oversight and assuring consistent…