Associate 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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

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:

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance leaders to support our growth in Kenosha County, Wisconsin. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Associate Director, Quality Assurance - Compliance has the responsibility for ensuring that the quality management system is established and effective. The individual in this role promotes awareness of management system requirements throughout the organization. The Associate Director is also responsible for the staffing, training, and leadership of the site compliance group in the design and development of key site compliance systems and procedures to support the implementation of the overall site Quality Management System (QMS).

Responsibilities:

• Supports the Site Compliance Leader in the development of the site the Quality Management System and execution of site quality programs
• Ensures that quality system requirements are effectively established and maintained in accordance with applicable regulatory requirements (e.g., EU Annex I, CFR, ISO13485)
• Leads reporting of the performance of the quality systems to site leadership and site flow/process team management
• Build a diverse and capable site compliance organization linked to the Lilly global organization in support of implementing and maintaining the site Quality Management Programs, systems, and procedures, including:
  • Deviation Management
  • Change Management
  • CAPA Management
  • Product Complaints
  • Site Self-inspection
  • Management Review
  • GMP Library and Document Control
  • QA for QC

• Fosters a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
• Supervises, coaches, and aids in employee development and performance management
• Ensures a fair and equitable work environment
• Networks with global and other parenteral and device assembly sites to understand best practices, share knowledge, and participate in tactical and strategic business planning
• Works cross-functionally across all areas of the site for coordination, planning, and execution of activities
• Sets human resource and business plan goals
• Plans and supports execution of site regulatory agency inspections
• Assists the Site Compliance in coordination and execution of the site Quality Plan.

Basic Requirements:

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or 10 years Quality experience in a manufacturing environment.
• 3 years in pharmaceutical leadership with specific Quality Management System experience, including leading or working effectively with a cross-functional group
• On-site presence required

Additional Skills/Preferences:

• Strong knowledge of Quality Management Systems, site compliance processes, and applicable regulatory requirements
• Previous parenteral manufacturing or device assembly experience
• Previous experience with pharmaceutical computer systems and applications including SAP, Veeva QDocs and TrackWise or similar systems
• 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 facility or area start up experience
• Previous equipment qualification and process validation experience
• Previous regulatory inspection readiness and inspection execution experience

Additional Information:

• Flex hours possible
• Primary location is Kenosha County, Wisconsin
• Ability to travel (approximately 10-20 %)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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