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Operations QA - Associate Director

Eli Lilly and Company
Concord, North Carolina
Start date
Jun 18, 2024

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Manufacturing & Production, Operations, Quality
Required Education
Associate Degree
Position Type
Full time
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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.


During the project phase, the Associate Director (AD), Operations is responsible for staffing, training, and leadership of the operations group supporting asset delivery, process development, operations readiness, start up, and validation of the parenteral operations (PAR) OR device, assembly, and packaging (DAP) areas. Once the facility is turned over to operations, the AD role is responsible for ensuring the group meets annual production goals as well as planning through 1-3 year horizons. The AD will be responsible for leading their respective cross-functional process teams. Direct line supervision for this role includes Supervisors and Operations Associates.

Key Objectives/Deliverables:

  • Comfortable with exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product impacting situation.
  • Lead/conduct area deviation and corrective action discussions with a cross-functional team from Engineering, Maintenance, Technical Services / Manufacturing Sciences (TS/MS), Quality, and Health, Safety, and Environmental (HSE) functional groups
  • Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for related inspections, tours, and discussions.
  • Ensure consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and Practice vs. Procedure evaluations.
  • Maintain and communicate metrics to measure performance against business objectives and make necessary changes to continuously improve.
  • Participate in the development and implementation of strategies focused on the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE).
  • Understand and influence the manufacturing control strategy for their area.
  • Support Site Leadership to build a diverse and capable site organization while delivering area operational procedures, quality processes and controls for the Parenteral/DAP manufacturing area.
  • Responsible for a work force of approximately 40 – 70 individuals on various shifts, with multiple shift supervisors and associates reporting directly to them.
  • Provide leadership and develop objectives to deliver Business Plan goals as it relates to production volumes, finances, safety, quality, stewardship, and people.
  • Act as a primary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering and Environmental/Safety.
  • Leading the Operations Process Team, a cross functional group charged with making medicine, continuous improvement, and site support.
  • Represent their Operations Process Team on the Plant Flow (value stream) Team.

Basic Qualifications:

  • Bachelor's degree in a STEM or pharmaceutical related field of study.
  • At least 7 years working in the pharmaceutical industry (preferably, with Parenteral or Device Assembly knowledge)
  • Previous management or leadership experience including leading or working effectively with a cross functional group.
  • Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and/or OSHA.
  • Excellence in; interpersonal, electronic, written, and oral communication
  • Strong technical aptitude and ability to train and mentor others

Additional Skills/Preferences:

  • 6+ years in manufacturing/operations with 4+ years in supervisory role
  • cGMP standards and FDA (or other industry) guidelines for production
  • Highly automated equipment (isolators, device assembly, packaging etc.)
  • Creation of standard operating procedures, work instructions, and training documentation.
  • Equipment & Facility design documentation reviews
  • Facility, equipment, or system start up.
  • Qualification and process validation experience.
  • Manufacturing Execution Systems and electronic batch release.
  • Automated Storage and Retrieval System (ASRS) Warehouses or AGVs.
  • Continuous improvement methodologies and mindset – lean, six sigma, etc.
  • Documentation, deviation and change management systems (e.g., Trackwise. Veeva, QualityDocs, Kneat)

Additional Information:

  • Ability to wear safety equipment (glasses, shoes, gloves, etc)
  • Ability to work 8 hours per day Monday through Friday with overtime as required to meet key objectives.

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 ( ) 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.



Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
893 S Delaware St
United States

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