Associate Director – QA – LAPI

Initial Therapeutics, Inc.; Lebanon (IN); On-site; USD 123,000 - 180,000; Full time

Benefits offered by this job

401(k) plan

Medical benefits

Well-being program

Job summary

Lilly is constructing a greenfield manufacturing site in Lebanon, IN and seeks an Associate Director – QA to lead QA teams, oversee cGMP quality, and ensure regulatory compliance across manufacturing, labs, and warehouses. The role partners with senior QA leadership to drive quality excellence and customer service.

Ideal candidates hold a BS in a scientific field or engineering with 5+ years in CGMP manufacturing and prior leadership experience.

Qualifications

• BS or equivalent in a scientific field or engineering.
• 5+ years in CGMP Manufacturing.
• Experience supervising/leading people.

Responsibilities

• Provide coaching/feedback to QA employees.
• Oversee productivity and development of QA staff.
• Maintain and improve quality systems; oversee inspections and audits.
• Ensure internal and external quality and supply commitments are met.
• Network with other sites regarding quality systems upgrades.

Skills

QA leadership

CGMP manufacturing

Regulatory affairs leadership

People supervision

Quality systems

Education

BS in science or engineering

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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.

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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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