Associate Director

4 weeks ago


Durham, North Carolina, United States BioSpace, Inc. Full time
Job Details

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We are headquartered in Indianapolis, Indiana, and our employees work together to discover and bring life-changing medicines to those who need them.

We are looking for a talented individual to join our team as an Associate Director - Quality Assurance (QA) Packaging. This role will be responsible for leading the quality assurance group and ensuring the staffing, training, and leadership of the team.

Responsibilities:
  • Support the site to ensure a safe work environment and lead safety efforts for the team
  • Build a diverse and capable site organization to support quality oversight and ensure compliance with area procedures and controls for labeling and packaging operations
  • Foster a strong quality culture, including maintaining open communications and promoting teamwork and employee participation in the work group
  • Demonstrate administrative leadership of a diverse team, including performance management and personnel development
  • Ability to utilize the team through active engagement and delegation to achieve results through others and deliver according to plan
  • Ability to manage multiple priorities in a fast-paced environment and deliver in accordance with established due dates
  • Ability to demonstrate flexibility with quick response as priorities change or issues arise
  • Support the development of the overall site operational readiness plan, including establishment and reinforcement of quality processes and approval of operational procedures
  • Work cross-functionally with the area process teams/flow team for metrics reviews, operational support, and issue/deviation management
  • Review and approve GMP documentation, including qualification/validation protocols and reports, procedures, deviations, technical reports, change controls, etc.
  • Partner with Associate Director for Device Assembly to set cohesive QA organization and operation to support DAP
  • Partner with production and design organization to ensure 24/7 Quality oversight and support
  • Engage and support Operational Excellence initiatives in DAP for monitoring performance and continuously improving the operation
  • Network with global and other DAP sites to understand best practices, share knowledge, and participate in tactical and strategic business planning
  • Support the Site Quality Leader in the development of the site organization, creation of the Quality Management System implementation plan, and execution of site quality operations in DAP
  • Active communication on project and production status
  • Define, lead, and/or support inspection readiness activities for operations and interact with Regulatory agencies during inspections
Basic Requirements:
  • Bachelor's degree in a science, engineering, computer, pharmaceutical-related field of study
  • 7 years of experience working in the pharmaceutical industry in QA/QC roles
Additional Skills/Preferences:
  • Previous facility or area start-up experience
  • Previous equipment qualification and process validation experience
  • Previous experience with SAP or other inventory management systems
  • Previous experience with highly automated combination products, packaging, and warehouse operations
  • Previous experience with Manufacturing Execution Systems and electronic batch release
  • Previous experience with automated material movement (central palletizing operation, automated warehousing)
  • CQM, CQE, or CQA certification from the American Society for Quality (ASQ)
  • Previous experience with deviation and change management systems, including Trackwise and Veeva
  • Previous management or leadership experience, including leading or working effectively with a cross-functional group
  • 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
Additional Information:

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.

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.

#WeAreLilly



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