Sr. Manager - QC Device and Incoming

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.

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 Device and Incoming QC Testing Team Leader provides direction and/or conducts an area’s daily workload planning, compliance, and overall customer service. The Team Leader must be committed to personnel interactions (approachable) and will spend considerable time as a mentor/supporter of reporting staff. The Team Leader also is responsible for coordinating laboratory analysts’ and technicians’ performance planning.  This role will be integral in designing and installing procedures and systems for the startup of the QC lab at the site.

Key Objectives/Deliverables:

• Proactively manage day-to-day business.  This includes interactions with project leaders, integration personnel, and management to plan, develop, and coordinate activities to set up the QC lab.
• Once the lab is functional, manage day-to-day business by interacting with production planners, sample submitters, et.al, to manage laboratory workload and throughput.
• Maintain a high-level understanding of the laboratory processes and responsible for analyst and technician training on methods and proper sample handling.
• Develop career plans for laboratory analysts and technicians.
• Enforce compliance to all procedures, methods, and other regulatory commitments.
• Provide technical understanding of the regulations applicable to laboratory testing for cGMP purposes.
• Serve as a team change agent, safety agent.
• Participate as primary laboratory subject matter expert for internal and external audits.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Basic Experience Requirements:

• Teamwork and interpersonal skills
• Strong verbal and written communication skills
• Deep understanding of compliance requirements and regulatory expectations
• Familiarity with device and incoming testing
• Ability to focus on continuous improvement.
• Minimum 7+ years of related experience in regulated environment.

Education Requirements:

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

Additional Skills/Preferences:

• Effective time management
• Effective problem-solving skills
• Experience with LabVantage LIMS.
• Demonstrated written and oral communication skills and ability to collaborate and interact with management, scientists, engineering, and IT personnel.
• Ability to manage and contribute to multiple concurrent project activities and adapt to changes in priorities.

Other Information:  

• 8 hour days – Monday through Friday
• Required to carry a mobile phone off shift and respond to operational issues.
• Travel may be