Lilly Manager-Quality 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.
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.
The Manager is responsible for managing the activities of Quality Assurance personnel supporting
Indy Parenteral Operations, with respect to regulatory requirements, procedural interpretation and
training, regulatory agency inspections and maintenance of inspection readiness within those areas.
Mentor, coach and/or provide feedback to employees
Manage or Assist with the department Budget, participate in organizational planning, development of business plan for area of responsibility
Exhibit cross-functional influence
Aid in Human Resource Development, Planning and Performance Management for direct reports
Participate on the Flow Lead Team and Site metrics reviews
Serve as a conduit for Corporate, Site and Functional communications
Approve GMP documents (example: Non-conformances, procedures, protocols, and change controls)
Participate in self-led and/or agency inspections
Basic Qualifications/Requirements :
Bachelors degree or equivalent experience
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
Responsible for maintaining a safe work environment, leading safety initiatives and working safely and accountable for supporting all HSE Corporate and Site Goals.
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
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.
May be subject to Post Offer Exam
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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!