Sr. Director - Quality Assurance - Radiopharmaceutical External Manufacturing

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Role Summary

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.

Responsibilities

• 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.

Qualifications

• 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 performance of contracted third party manufacturing organizations
• Required: Highly experienced in auditing manufacturing processes to meet GMP standards in multiple regions or countries
• Required: Excellent working knowledge of FDA and EMA GMP regulations, guidelines, and compendial standards, including radiopharmaceuticals
• Required: Authorized to work in the United States on a full-time basis
• Preferred: An advanced degree (e.g. MS/PhD) in a scientific discipline relevant to drug discovery and development
• Preferred: Several years’ experience in parenteral therapeutic drug development is strongly preferred
• Preferred: Knowledgeable and experienced working under R&D GMP governing standards from Early to Late Phase development and Commercially approved products.
• Preferred: Able to interpret GMP standards into phase-appropriate, efficient, and compliant working procedures
• Preferred: Experienced working under corporate global standards and assuring unique product standards are effectively designed into corporate quality management systems
• Preferred: Knowledgeable of radiopharmaceutical manufacturing standards and unique features of radiopharmaceutical standards and manufacturing processes is a plus.
• Preferred: Familiarity with manufacturing scale up and technology transfer
• Preferred: Highly experienced in contract manufacturing Quality Assurance from identification through routine oversight and termination
• Preferred: Excellent knowledge and experience in third party drug product manufacturing relationships, effective performance monitoring and management, and issue resolution
• Preferred: Experience working on Early-Late Phase development projects, commercial product launches and overseeing commercial product CDMOs
• Preferred: Experienced in designing site Quality Management Systems in alignment with Corporate global standards
• Preferred: Demonstrated success leading supervisors and experienced technical staff located in multiple regions globally for their success and career development
• Preferred: Qualified Person trained and/or certified
• Preferred: Ability to travel domestic and internationally 15–20%

Additional Requirements

• Location: onsite in Philadelphia, PA with the ability to work from home up to two days per week. Remote work may be considered.
• Travel: Domestic and international travel 15–20%

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