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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.

Position Title:

Sr. Manager - QC Chemistry and Device

Job Level:

M1

Job Family Group/Family

Quality Control

Supervisor:

Associate Director - Quality Control Labs - RTP

Location:

Research Triangle Park

Position Description:

The Sr. Manager, Quality Control (QC) – Chemistry and Device leads a team of laboratory personnel supporting routine device, water, and drug product testing. The Sr. Manager is responsible for scheduling and planning laboratory testing, laboratory data review and laboratory project support activities. The Sr. Manager may oversee or assist in the onboarding on laboratory instrumentation and equipment, including authoring/reviewing/executing change controls and related actions, authoring/reviewing IQ/OQ/PQ protocols and reports, authoring/reviewing/approving standard operating procedures and training materials as well as working with and/or overseeing certified service providers during instrument installation and/or repair activities. The Sr. Manager will be responsible for oversight of personnel learning plans, including assigning training courses as needed, development and maintenance of departmental training matrixes and scheduling training for personnel managed. The Sr. Manager will be required to utilize technical and regulatory expertise to assist in inspection/audit related activities, laboratory investigations and continuous improvement initiatives. The Sr. Manager will provide support to cross-functional quality control teams, such as microbiology and environmental monitoring, as needed.

Key Objectives/Deliverables:

+ Proactively lead a team of laboratory analysts.

+ Effectively manage departmental workload, including collaboration with other laboratory leadership personnel on scheduling activities and prioritization of projects/testing/deliverables.

+ Communicate with other laboratory leaders to ensure effective cross-shift communication.

+ Provide technical and administrative leadership within the laboratory team, cross-functionally and across sites, as required.

+ Author and/or approve investigations/deviations, CAPAs and change controls, as required.

+ Lead and manage relationships with contract personnel, as required.

+ Provide support for internal and external auditing processes, including acting as a key presenter and tour lead for areas managed.

+ Coach and develop team, including one-on-one meetings, performance management and development plans.

+ Support other laboratory personnel within the microbiology and environmental monitoring teams, with escalations and problem resolution.

Requirements (Education, Experience, Training):

+ Bachelor (4-year college) degree in a life or applied science (Chemistry preferred)

+ At least five years of relevant, hands-on experience working within a GMP laboratory.

+ Able to provide on call support, as required.

Preferred attributes but not required:

+ Experience with electronic laboratory management systems (E.g., LIMS, LES, ELN)

+ Experience with electronic document management systems, such as VeevaVault.

+ Laboratory experience with various analytical instrumentation (E.g., UV-Vis, pH, Conductivity, TOC).

+ Experience with medical device testing, including variables and attributes testing.

+ Experience in operational excellence, such as lean and 5S initiatives.

+ Demonstrated problem solving and analytical thinking skills.

+ Excellent interpersonal skills and networking skills.

+ Experience with collection and presentation of KPIs and metrics.

+ Demonstrated written and verbal communications skills.

+ Strong attention to detail.

+ Demonstrated ability to work both independently and as a part of a Team.

+ Strong organizational skills.

+ Excellent leadership and communication skills.

**Additional Information** :

+ 8-hour days – Monday through Friday, 9PM – 5AM, with on-call off-shift support as needed in support of a 24/7 manufacturing operation.

+ Applicant will work in various areas within the site. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.

+ Tasks may require repetitive motion (E.g., keyboarding).

+ Minimal travel 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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$94,500 - $138,600

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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