Associate Director - QA IAPI

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 Brand Description:

The Associate Director - QA is a partner with the Sr. Director - QA in ensuring that operations have robust quality oversight. The Associate Director - QA is primarily responsible for the productivity and development of the QA employees, the quality of the product/results, oversight of manufacturing and support operations and overall customer service. It is expected that the Associate Director will oversee the department's performance, resolution of quality issues, and regulatory compliance.

Key Objectives/Deliverables:

• Provide coaching/feedback to and develop QA employees.
• Utilize Human Resources tools to ensure that the right individuals are in the right job (e.g., Performance Management, Merit Delivery, Talent Assessment, Succession Planning and Staffing).
• Participate in organizational planning.
• Provide input into the business plan and ensure conformance to department budget for area of responsibility.
• Exhibit cross-functional influence.
• Maintain and improve quality systems.
• Approve deviations, procedures, protocols, and change controls.
• Develop and maintain processes that support inspections and audits; prepare individuals to interact with auditors and inspectors.
• Participate in site self-assessments and regulatory agency inspections.
• Ensure internal and external quality and supply commitments are met.
• Provide quality management oversight for API manufacturing, laboratories and warehouses.
• Investigate complaints.
• Manage the creation, revision and maintenance of cGMP documents (e.g., job aids, procedures, forms, job descriptions).
• Provide oversight and review of changes to the Global Quality Standards and ensure local implementation of changes.
• Network with other sites regarding new or current quality systems.

Basic Requirements:

• BS or equivalent in a scientific field or engineering.
• Knowledge of cGMPs.
• Experience in Manufacturing, QC, QA, Technical Services, Engineering or Regulatory Affairs.

Additional Preferences:

• Previous experience supervising/leading people.
• Demonstrated strong written and verbal communications skills.
• Strong attention to detail.
• Understanding of statistical tools and analysis.
• Excellent interpersonal skills and networking skills.
• Ability to organize and prioritize multiple tasks.
• Demonstrated strong problem solving and analytical thinking skills.
• Ability to influence diverse groups.
• Demonstrated understanding of computer applications.

Other Information:

• Must complete Learning Plan for Associate Director - QA - IAPI.
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
• Must carry a cell phone to support 24 hour/day operations.

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 ( [email protected] ) 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.

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