Hybrid Senior Director – Quality Assurance, Radiopharmaceutical External Manufacturing

at Eli Lilly and Company

• Job title: Senior Director – Quality Assurance, Radiopharmaceutical External Manufacturing
• Job type: Full Time
• Experience level: Senior
• Salary: $156,000 - $253,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Philadelphia, United States

About the role

• Director of Quality Assurance directing quality oversight and control strategy for Radiopharmaceutical contract manufacturing. Collaborating across teams to ensure compliance and quality for Lilly's drug products.

Responsibilities

• 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

Benefits

• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)