Senior Director, Quality

at  Lilly

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.

ORGANIZATION OVERVIEW:

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 are looking for people who are determined to make life better for people around the world.
Lilly is designing and building a Next-Generation Parenteral and Device Assembly/Packaging Facility in Alzey, Germany. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up. Our new Alzey facility will be one of Lilly’s most technically advanced manufacturing sites and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.

BASIC REQUIREMENTS:

• Bachelor of Science degree in a scientific field (e.g., pharmacy, chemistry, microbiology, engineering)
• Minimum of 10 years’ experience in the pharmaceutical industry in parenteral operations
• Minimum of 10 years of leadership experience (Ideally in Quality Assurance)
• Hosting regulatory inspections
• Fluent in English and German
• On-site presence required

ADDITIONAL SKILLS/PREFERENCES:

• Demonstrated Technical writing ability
• Demonstrated strong oral and written communication
• Demonstrated ability in problem solving and critical decision-making
• Demonstrated ability to coach, mentor and lead others
• Demonstrated interpersonal skills with ability to influence cross-functionally and externally
• Demonstrated self-motivated leadership, ensuring a fair and equitable work environment
• Clear understanding of cGMPs, policies, procedures, and guidelines
• Demonstrated ability to maintain a safe work environment

The Senior Director, Alzey Site Quality leader, is primary responsible for ensuring that an effective Quality Management System is in place. This includes ensuring compliance with cGMPs, policies, procedures and standards that are required to support parenteral manufacturing, device assembly, and packaging. They effectively influence the leadership on strategic direction and tactical implementation of the quality system. The individual in this role establishes the site´s quality objectives, priorities, and roadmap. The senior director leads and/or participates in the assessment, development, and implementation of critical projects in support of continuous quality improvements. This may include new facility delivery or existing facility expansion/recapitalization. He/she will also provide quality support for achieving key business objectives.
The quality leader provides leadership and direction in managing product-related quality matters, assuring the independence of the quality unit, while making decisions regarding quality issues. This individual ensures that the products are fit for their intended use and comply with global regulatory requirements. The Senior Director, Alzey Site Quality Leader, together with the Qualified Person, leads and responds to regulatory agency inspections and inquiries.