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Lilly Sr. Manager QA Operations in Indianapolis, Indiana

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 35,000 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 Quality Assurance Team assures patients worldwide of safe and efficacious drug products, through effective quality oversight of Indianapolis Parenteral Operations activities.

The Sr Manager for QA Operations is responsible for providing leadership and daily support and oversight to GMP operations at Indianapolis Parenteral Manufacturing. The Sr Manager assists the Associate Director in managing daily work of personnel and tracking department metrics to ensure productivity and alignment with departmental/site goals. The Sr. Manager is also responsible for individual contributor activities that may include SME and Process Owner within area of responsibility as well as process improvements.

Key Objectives / Deliverables:

Team and personnel development:

  • Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports, recruit new talent and grow team capabilities

  • Mentor, coach and provide feedback to employees for performance and development

  • Ensure adequate staffing and coverage within areas of responsibility

  • Develop, lead, and support the site Safety, Quality and Compliance initiatives and culture.

  • Scope of team may comprise of on-shift support (exempt and non-exempt), stat sort inspectors, and/or batch review quality reps.

Quality and Compliance oversight:

  • Own and maintain programs/processes related to area

  • Exhibit critical business decision making taking into consideration quality, compliance and business aspects, escalate critical quality issues, when appropriate, on a timely manner and proposing decisions into the escalation forum (e.g Flow Team, Plant Lead Team)

  • Support Site Quality Plan; maintain technical and compliance consistency across plants

  • Ensure Plant inspection readiness

  • Participate and when needed to support regulatory inspections

  • Exhibit cross-functional influence to promote quality culture and maintain supply of quality product to patients

  • Act as primary back-up for other Quality Assurance Sr. Managers and, upon delegation of authority, the Associate Director.

Basic Qualifications:

  • Bachelor’s degree

Additional Preferences:

  • Previous experience with Lilly non-conformance and change control process

  • Experience in Production, QC, QA, Technical Services, Engineering or Regulatory is desirable.

  • Knowledge of cGMP's

  • Technical writing and written communication skills are a plus

  • Six Sigma Green Belt or Black Belt certification

  • Demonstrated relevant experience in a GMP facility

  • Proficiency with computer systems including Microsoft Office products

  • Demonstrate strong oral and written communication and interpersonal skills

  • Experience with being a mentor, coach and/or giving and receiving feedback

Other Information:

  • Overtime may be required

  • May be required to respond to operational issues outside of core business hours and days.

  • Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.

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 ( LillyRecruitingCompliance@lists.lilly.com ) 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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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