Associate Director

5 days 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. Our employees work together 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're looking for individuals who are determined to make a positive impact on people's lives.

Job Summary
The Associate Director - Quality Assurance (QA) Packaging is responsible for leading the quality assurance group supporting project/expansion delivery, process development, operational readiness, start-up, and validation of packaging processes in the Device Assembly and Packaging (DAP) production area at Lilly RTP. This role will help build a strong quality culture and lead the QA team for oversight and support of ongoing operations, site inspection readiness, and execution.

Responsibilities
  • Ensure a safe work environment and support 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 through open communications and teamwork, promoting employee participation in the work group
  • Lead a diverse team, including performance management and personnel development
  • Utilize the team through active engagement and delegation to achieve results and deliver according to plan
  • Manage multiple priorities in a fast-paced environment and deliver results in accordance with established due dates
  • 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 area process teams/flow teams 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 the Associate Director for Device Assembly to set a cohesive QA organization and operation to support DAP
  • Partner with production and design organizations 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 developing the site organization, creating the Quality Management System implementation plan, and executing site quality operations in DAP
  • Communicate project and production status actively
  • Define, lead, and/or support inspection readiness activities for operations and interact with regulatory agencies during inspections

Requirements
  • Bachelor's degree in a science, engineering, computer, or pharmaceutical-related field of study
  • Experience working in the pharmaceutical industry in QA/QC roles

Preferred Skills
  • 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
  • Ability to work 8-hour days, Monday through Friday
  • Ability to work overtime and weekends as required to support the 24/7 production floor operation
  • Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations

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