Sr Manager, Quality Control – Laboratory Operations

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.

Company Overview:

Lilly is a fortune 500 company in operation for over 140 years creating high-quality medicines for our patients while living our company values of Integrity, Excellence, and Respect for People in everything that we do.

Organization Overview:

Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly 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 Quality Control Laboratory assures patients worldwide of safe and efficacious drug and device products, through effective execution of product testing.

The Sr. Manager, Quality Control (QC) – Laboratory Operations leads a team of laboratory personnel supporting routine device testing, stability program management and laboratory support activities. The Sr. Manager is responsible for scheduling and planning activities as related to laboratory testing, laboratory equipment/instrumentation management and stability program management.  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 and development and maintenance of departmental training matrixes.  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.    

Key Objectives/Deliverables:

• Proactively lead a team of laboratory analysts and laboratory support personnel.
• Effectively manage departmental workload, including developing and/or overseeing scheduling activities, prioritization of projects/testing/deliverables, ensuring even workload distribution and effective communication within teams managed.
• Provide technical and administrative leadership within the laboratory team, cross-functionally and across sites, as required.
• Review and approve investigations/deviations, CAPAs and change controls, as required.
• Lead and manage relationships with third party testing laboratories, as required.
• Provide support for internal and external auditing processes, including acting as a key presenter and tour lead for areas managed.

Requirements:

• 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.

Additional Preferences:

• Experience with electronic laboratory management systems (E.g., LIMS, LES, ELN)
• Experience with Empower3 and TrackWise.
• Laboratory experience with various analytical instrumentation (E.g., HPLC, UV-Vis, Osmometry, pH, Conductivity, TOC).
• Experience with commercial stability program management.
• 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.
• Proficiency in use of statistical tools for trend analysis.
• 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.
• May be required to provide on call support.
• 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, with on-call 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.

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 ( Lilly_Recruiting_Compliance@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.

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