Associate Director - QA Parenteral at Eli Lilly and Company

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.

Associate Director Quality Assurance (QA) Parenteral is responsible for the staffing, training, and leadership of the quality assurance group supporting the project/expansion delivery, process development, operational readiness, start up, and validation/qualification of the parenteral process including dispensing, equipment preparation, formulation, filling and visual inspection.  The Associate Director will help build a strong quality culture and lead the QA team for oversight and support of the ongoing operation as well as site inspection readiness and execution.

Responsibilities:

• Supporting the site to ensure a safe work environment including supporting and leading safety efforts for team
• Build a diverse and capable site organization to support quality oversight, and ensure compliance with area procedures and controls for parenteral operations
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
• Demonstrated administrative leadership of a diverse team including performance management and personnel development.
• Ability to utilize 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 production and design organization to ensure 24/7 Quality oversight and support
• Engage and support Operational Excellence initiatives for monitoring performance and continuously improving the operation
• Network with global and other parenteral network 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 parenteral production
• 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 or equivalent experience.
• 7+ years of experience in a Quality role supporting pharmaceutical/medical device manufacturing.

Additional Skills/Preferences:

• Experience working in the pharmaceutical industry in QA/QC roles
• Previous experience in parenteral production support
• 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
• 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 parenteral manufacturing processes including isolators, automated inspection, etc.
• 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

Additional Information:

• Ability to work 8-hour days – Monday through Friday
• Ability to work overtime as required
• Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations

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