Senior Director, Quality Assurance

2 months ago

Pleasant Prairie, United States Eli Lilly and Company Full time

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 skills 
      • Strong technical aptitude and ability to train and mentor others 
      • Demonstrated technical writing skills
      • Demonstrated problem-solving and decision-making skills
      • Previous experience with deviation and change management systems (e.g., Trackwise, Veeva)


        Additional Information:

        • Ability to work 8-hour days – Monday through Friday (on-site)
        • Ability to work overtime as required 
        • Ability to travel 10-25% of the time may be required

          Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

          Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

          Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

          #WeAreLilly

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