QA Manager-Night Shift

Night Shift Manager, Quality Assurance (QA) – Device Assembly and Packaging (DAP)

The Night Shift Manager, Quality Assurance will support the start-up and routine operation of the QA organization overseeing Device Assembly and Packaging operations at Lilly’s Concord, North Carolina pharmaceutical manufacturing site. Responsibilities include technical and administrative leadership as well as project management.

• Serve as a technical resource to review and approve technical documents
• Network with cross-functional technical project delivery teams to ensure equipment and systems comply with quality requirements and are implemented with a Quality by Design framework
• Work with the Associate Director, Quality Assurance to support the development of the vision, strategy, and quality culture for the overall site quality assurance organization with a focus on the device and packaging programs
• Support initial recruiting, build capability, and develop a diverse leadership and quality assurance staff to support qualification, validation, and routine production
• Manage a team of up to approximately 14 direct reports
• Support the site to ensure a safe work environment, including leading safety efforts for the team
• Support the development of the overall site operational readiness plan, including the development of quality processes and approval of operational procedures and controls
• Foster a strong quality culture by maintaining open communications and promoting teamwork and employee participation in the work group
• Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment
• Review and approve GMP documentation, including procedures, deviations, technical reports, change controls, and more
• Network with global and other device assembly sites to understand best practices and share knowledge
• Work cross-functionally with area process teams for metrics reviews, operational support, and issue/deviation management
• Support inspection readiness activities
• Interact with regulatory agencies during inspections regarding cGMP issues
• Ensure data integrity by design

• Bachelor’s degree in a science, engineering, pharmaceutical‑related field of study or equivalent experience
• 5+ years in pharmaceutical leadership with specific QA experience, including leading or working effectively with a cross‑functional group
• Qualified applicants must be authorized to work in the United States on a full‑time basis;
  Lilly will not sponsor work authorization

• Commit to successfully maintain Lilly Computer System Quality Assurance (CSQA) certification
• Strong knowledge of Quality Management Systems and applicable regulatory requirements
• Previous experience directly supporting a pharmaceutical manufacturing operation
• Excellent interpersonal, written and oral communication skills
• Strong technical aptitude and ability to train and mentor others
• Demonstrated technical writing skills
• Demonstrated problem‑solving and decision‑making skills
• Previous facility or area start‑up experience
• Previous equipment qualification and process validation experience
• Previous experience with highly automated combination products and packaging equipment
• Previous experience with Manufacturing Execution Systems and electronic batch release
• CQM, CQE, or CQA certification from the American Society for Quality (ASQ)
• Previous experience with deviation and change management systems, including Trackwise

• Ability to work 8‑hour days — Monday through Friday, night shift
• Ability to work overtime as required
• Ability to travel 10–25% or potentially relocate during the project phase to support the design and staffing of the facility
• May be required to respond to operational issues outside of core business hours and days

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 this position, please complete the accommodation request form () for further assistance. Please note this is for individuals to request an accommodation as…