Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the site team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility, and the culture to enable a successful startup into GMP manufacturing operations.
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 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.
- 5+ years in CGMP Manufacturing.
Additional Preferences:- Knowledge of cGMPs.
- Experience in Manufacturing, QC, QA, Technical Services, Engineering or Regulatory Affairs Leadership
- 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 - LAPI.
- No certifications required.
- Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
- Must support 24 hour/day operations.
- Some travel may be required.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$123,000 - $180,400
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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