Associate Director, Quality Assurance – Materials

Industry:

Company: Eli Lilly and Company

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
$118,500 – $173,800

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 (QA) – Materials, will lead the start-up and routine operation of the QA organization overseeing the Materials Management and Logistics operations at Lilly Kenosha County (LKC). Responsibilities include technical and administrative leadership, as well as project management.

Responsibilities:

• Serve as technical resource to review and approve materials management documents (e.g., qualification documents, change controls, procedures, quality agreements)
• Network with cross-functional resources to ensure establishment of the materials management quality system
• Facilitate project delivery through support of materials implementation associated with site expansion
• Work with the Site Quality Leader to support the development of the vision, strategy and quality culture for the overall site quality assurance organization with focus on materials management, supplier and service provider governance and logistics activities.
• Support initial recruiting, build capability, for a diverse quality assurance staff
• Support the site to ensure a safe work environment including supporting and leading safety efforts for your team
• Establish site material supplier program, partnering with other Lilly manufacturing sites and global materials management teams
• Build the team to develop and maintain the approved supplier list, Quality Agreements, material and supplier risk assessments, and periodic reviews of supplier performance
• Provide support to the warehouse and logistics for all operational quality assurance needs and materials approvals
• Responsible for materials and supplier complaint handling
• Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures and controls
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
• Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment
• Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
• Participate in tactical and strategic business planning

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 Materials QA experience, including leading or working effectively with a cross-functional group
• On-site presence required

Additional Skills/Preferences:

• Strong knowledge of Quality Management Systems and applicable regulatory requirements
• Previous materials management and supplier management experience
• Previous experience with material management 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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