Senior Director, Quality Assurance - Compliance

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:
Lilly is expanding capability at a new state of the art Parenteral Facility in Kenosha County, Wisconsin.  This is an exciting opportunity to help build upon an existing foundation to expand reach to the patients we serve.  The Quality Assurance (QA) organization ensures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of the Quality Management System. QA actively participates in the commercialization and supply of medicines that help people live longer, healthier, more active lives. QA provides support of key therapeutic area strategies to increase the value of Lilly products.

The Senior Director - Quality Assurance - Compliance will oversee site compliance at the Lilly Kenosha County site. This role is responsible for leading all activities in support of site registration and approval including maintaining a constant state of inspectional readiness. The Senior Director will manage all regulatory inspection logistics including direct hosting of agency inspections. This individual will foster a strong quality culture and cultivate operational excellence through demonstrated quality leadership. 

Responsibilities:
The Senior Director - Quality Assurance - Compliance serves as the site compliance officer. The individual in this role ensures compliance with all cGMP procedures, policies and guidelines and supports development of the business plan for this focus.  The incumbent will have primary responsibility for inspectional readiness and, as such, must have an in-depth understanding of Lilly’s Global Quality Management System and its application within an operational manufacturing site. Key responsibilities include:

• Lead the site inspection readiness program, ensuring that Lilly Kenosha County is inspection-ready at all times
• Coordinate and manage all regulatory inspection logistics including direct hosting of agency inspections
• Ensure that processes needed for the Lilly Kenosha County quality management system are established and documented
• Monitor and report on the effectiveness of the quality management system including needed improvements
• Ensure awareness of applicable regulatory and quality management system requirements throughout the organization
• Sponsor site initiatives related to quality and compliance
• Act as connection for global initiatives related to quality and compliance for local implementation
• Create and manage the Site Master File, Site Quality Plan, and Site Quality Manual
• Ensure adequate governance of key quality processes at the site (e.g., site quality lead team, management reviews of quality systems).
• Provide direction for the site-wide quality governance boards (e.g., site quality lead team, deviation review board, change control review board)
• Participate on the site and external governance committees as needed
• Serve as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for individual contributors and management at the site
• Lead and model behaviors foundational to strong quality culture
• Act as liaison with Regulatory for Site Licenses and declarations, Site Master file, and other regulatory compliance related documents
• Benchmark with external sources to understand industry trends and share with internal quality organizations.
• Support site safety initiatives.

Basic Requirements:

• Bachelor's degree in a science, engineering, pharmaceutical-related field of study or equivalent experience
• 10+ years in pharmaceutical manufacturing with specific QA experience, including inspectional readiness and regulatory inspection management

Additional Skills/Preferences:

• Strong knowledge of Quality Management Systems and applicable regulatory requirements including cGMP and ISO
• Previous experience hosting regulatory and notified body inspections (e.g., FDA, EMA, DEKRA)
• Previous auditing experience
• Previous experience directly supporting a pharmaceutical manufacturing operation 
• Excellent interpersonal, written and oral communication sk