Sr. Manager-QC Environmental Monitoring & Utilities
: Job Details :

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.

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

Company Overview:

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 39,000 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. #WeAreLilly

Organization Overview:

Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment.

Position Brand Description:

The Sr. Manager, Quality Control (QC) Environmental Monitoring (EM) & Utilities provides direction and/or conducts area's daily workload planning, compliance, and overall customer service. 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:

• Ensures that all team members are knowledgeable and compliant regarding safety procedures, policies, permits and practices.
• Provide technical and administrative leadership within the EM team, cross-functionally and across sites, as required.
• Accountable for the team meeting the quality standards as defined by cGMPs, Global Quality Standards, local procedures and production tickets (as applicable).
• Provide support for internal and external auditing processes, including acting as a key presenter and tour lead for areas managed.
• Review and approve investigations/deviations, CAPAs, and change controls, as required.
• Responsible for managing daily operations across shifts including attendance, overtime, training, performance coaching, team development and issue resolution/escalation.
• Responsible for meeting the daily, weekly, and monthly sample schedule, uninterrupted support for Operations and escalating issues timely.
• Coordinates with external teams and functions as required on projects critical to success.
• Drives and/or supports continuous improvement through data collection, evaluation and effective implementation of solutions.

Basic Experience Requirements:

• 5+ years' experience leading and developing people
• Teamwork and interpersonal skills
• Strong verbal and written communication skills
• Deep understanding of compliance requirements and regulatory expectations
• Demonstrated proficiency and understanding of aseptic technique, environmental monitoring in aseptic filling environments and cleanrooms, and clean utility systems.
• Ability to focus on continuous improvement.

Education Requirements:

• Bachelor or Masters in a science or engineering discipline (Microbiology, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.)

Additional Skills/Preferences:

• Experience with LabVantage LIMS, TrackWise, and Veeva.
• Experience with MODA.
• Demonstrated written and oral communication skills and ability to collaborate and interact with management, scientists, engineering, and IT personnel.
• Experience in operational excellence, such as lean and 5S initiatives.
• Experience with collection and presentation of KPIs and metrics.
• Strong organizational skills.
• Excellent leadership and communication skills.
• Ability to manage and contribute to multiple concurrent project activities and adapt to changes in priorities.
• Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations

Other Information:

• 8 hour days – Monday through Friday
• Required to carry a mobile phone off shift and respond to operational issues.
• Minimal travel required.
• Ability to work in various areas within the site. Some allergens are present in the parenteral plant.
• Tasks may require repetitive motion (e.g., keyboarding).

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 ( 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 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.

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.

#WeAreLilly