Sr. Manager, Quality Control - Chemistry & Device

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.

This is an exciting opportunity to help a state-of-the-art facility and Quality System. The Quality Control Laboratory assures patients worldwide have safe and efficacious drug and device products, through effective execution of product testing

Position Description:

The Sr. Manager, Quality Control (QC) – Chemistry and Device leads a team of laboratory personnel supporting routine and non-routine device, water, and drug product testing. The Sr. Manager is responsible for scheduling and planning activities as related to laboratory testing, laboratory data review and technical transfer/laboratory project support. 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.    

Key Objectives/Deliverables:

• Proactively lead a team of laboratory analysts.
• 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.
• 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.

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.
• At least two (2) years of leadership experience.
• Able to provide on call support as needed in support of a 24/7 manufacturing operation.
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Preferred attributes but not required:

• 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 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:

• Applicant will work in various areas within the site.  Some allergens are present in the parenteral plant. Mo