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:

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.

The Sr Manager for QA Visual Inspections Operations is responsible for providing leadership and daily support and oversight to STAT/SORT operations at Research Triangle Park Parenteral Manufacturing facility. The Sr Manager assists the Associate Director-QA Parenteral in managing daily work of personnel and tracking department metrics to ensure productivity and alignment with departmental and site goals. The QA Sr. Manager ensures QA oversight of the AQL and batch sampling process to meet business requirements. The QA VI 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.

Responsibilities:

• Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals.

• Responsible for managing 4 - 8 QA VI Technicians supporting the AQL sampling, inspection and sample submission for the semi-finished syringe visual inspection process. Ensures adequate staffing and coverage within area of responsibility.

• May be required to support inspection based tasks.

• 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.

• Ensures adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel.

• Lead, mentor, and coach Quality VI technicians, Operations, and support personnel on quality matters, such as AQL and sampling, while driving the site Quality culture.

• Responsible for ensuring team is trained and training remains in compliance.

• Ability to assess, create, and triage deviations / observations that occur within the parenteral areas.

• Reviews and approves GMP documentation in support of daily operations such as: Maintenance Action Plans, Return to Service and Release of equipment, product, and area holds, spare parts consultation, work order assessments and issue resolution, and other documentation as required.

• Troubleshoot and provide QA systems support to reconcile issues in multiple systems (i.e., SAP, PMX. TrackWise, SmartLab, GMARS, and other systems as required.)

• Participate in self-led inspections and provide support during internal / external regulatory inspections.

• Review and / or redline to GMP documents ensure quality attributes are met. (i.e., deviations / observations, procedures, production records, etc.).

• Communicates with Associate Director and Quality Representatives on quality and operational issues.

• Work cross functionally and collaboratively with all levels of the organization.

Basic Requirements:

• Bachelor’s degree or equivalent experience

• 5 years experience in quality role supporting parenteral manufacturing operations.

• Experienced in performing AQL post visual inspection via manual, semi-automated and automated inspection processes.

Additional Skills/Preferences:

• Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.

• Demonstrated strong oral and written communication and interpersonal skills.

• Demonstrated decision making and problem-solving skills.

• Demonstrated knowledge and understanding of manufacturing process and Quality Systems.

• Proficiency with inventory management systems and deviations systems, (i.e. SAP, Trackwise, etc.)

• Strong attention to detail

• Proven ability to work independently or as part of a team to resolve issues.

Additional Information:

• Position is first shift Monday - Friday.

• Pass visual exam for 20/20 vision with or without correction and must pass colorblindness exam.

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

• Ability to work overtime, as requested.

• Applicant may work in various areas within Parenteral Building. Mobility requirements 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.

#WeAreLilly