Associate Director - QA IAPI

Eli Lilly and Company • Indianapolis, IN

1d • Hybrid

About The Position

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: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Responsibilities: The Associate Director – Quality Assurance (QA) is responsible for managing the activities of QA personnel supporting the oversight of Insulin Active Pharmaceutical Ingredient (API) manufactured within Indianapolis Active Pharmaceutical Ingredient (IAPI) manufacturing site. 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. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation. The position requires working cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives. Inspection Readiness focus through developing and maintaining processes that support inspections and audits; prepare individuals to interact with inspectors and auditors. Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency inspections. Conduct performance management and development of QA staff; Partner within QA and across functional disciplines to influence and implement the site continuous improvements, site business plan objectives, and GMP Quality Plan objectives 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. Review and approve deviations, procedures, protocols, and change controls with focus for improving the overall manufacturing and/or business processes Participate in 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.

Requirements

• Bachelor’s Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field.
• 5+ years of experience in pharmaceutical manufacturing environment in any of the following associated disciplines: TSMS, Production, Quality Assurance, Quality Control, Engineering, Project Management, Development, Procurement.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

• Experience in Manufacturing, QC, QA, Technical Services, Engineering or Regulatory Affairs.
• Excellent interpersonal skills and networking skills.
• Ability to organize and prioritize multiple tasks.
• Demonstrated strong problem solving and analytical thinking skills with strong attention to detail.
• Demonstrated understanding of computer applications.
• Demonstrated strong written and verbal communications skills.
• Ability to influence and lead diverse groups; communicate and influence effectively across functional groups and stakeholders
• Understanding of statistical tools and analysis.
• Previous experience supervising/leading people.
• Influences complex regulatory, business, or technical issues within the site and function
• Builds relationships with internal and external customers and partners
• Demonstrated Project Management skills and ability to coordinate complex projects
• Strategic thinking and ability to balance short term needs with long term business evolution
• Enthusiasm for changes, team spirit and flexibility
• Experience working with Syncade, Veeva, Tulip, and Delta V
• Expernce with Copilot, Calude, etc...

Responsibilities

• Managing the activities of QA personnel supporting the oversight of Insulin Active Pharmaceutical Ingredient (API) manufactured within Indianapolis Active Pharmaceutical Ingredient (IAPI) manufacturing site.
• Productivity and development of the QA employees, the quality of the product/results, oversight of manufacturing and support operations and overall customer service.
• Oversee the department’s performance, resolution of quality issues, and regulatory compliance.
• Working cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives.
• Inspection Readiness focus through developing and maintaining processes that support inspections and audits; prepare individuals to interact with inspectors and auditors.
• Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency inspections.
• Conduct performance management and development of QA staff
• Partner within QA and across functional disciplines to influence and implement the site continuous improvements, site business plan objectives, and GMP Quality Plan objectives
• 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.
• Review and approve deviations, procedures, protocols, and change controls with focus for improving the overall manufacturing and/or business processes
• Participate in 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.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level