Sr. Director - Quality Assurance - Radiopharmaceutical External Manufacturing

Eli Lilly and Company • Philadelphia, PA

28d • $156,000 - $253,000 • Hybrid

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Position Overview: This position is responsible for developing and carrying out the control strategy, routine quality oversight, risk management, and continuous improvement of a globally based large network of Radiopharmaceutical contract manufacturers for the reliable supply of investigational and commercially approved Lilly compounds, out licensed and externally purchased products. This role ensures phase appropriate CDMO qualification and third-party quality oversight is established and remains successful. This position defines goals in support of company objectives and collaborates with Global Quality Systems for developing or effectively integrating the unique challenges with radiopharmaceuticals with company standards. The individual works closely with R&D, CMC, Global External Manufacturing, Lilly Affiliates, leadership, and project teams to plan for and execute these responsibilities. This role interfaces with external trade and pharmaceutical associations to support the evolving Radiopharmaceutical regulatory landscape, new product innovation, articulating unique guidelines for the manufacture of radiopharmaceuticals, and the global delivery of products. As lead of global contracted radiopharmaceutical manufacturing, this role is responsible for organizational and resource management, staff development, and career planning. The individual manages a functional team of professional staff responsible for establishing the quality oversight strategy and maintaining drug product CDMOs manufacturing at various stages of development from Phase 1-3 and commercially marketed products. This position works with business and compliance team members to identify solutions including automated and AI opportunities to drive efficiencies in work effort, time, right first time, and an increase in productivity.

Requirements

• Bachelors degree discipline relevant to drug discovery and development (ie. Life Sciences) or relevant to pharmaceutical manufacturing
• 10+ years of quality assurance experience in drug development and novel commercially manufactured therapeutic agents.
• Expertise in establishing quality oversight and assuring consistent performance of contracted third party manufacturing organizations
• Highly experienced in auditing manufacturing processes to meet GMP standards in multiple regions or countries
• Excellent working knowledge of FDA and EMA GMP regulations, guidelines, and compendial standards, including radiopharmaceuticals
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

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

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.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Director