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.
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.

POSITION OVERVIEW:

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance leaders to support our growth in Alzey, Germany. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.
The Associate Director, Quality Assurance (QA) – Parenteral, is responsible for staffing, training, and leadership of the quality assurance group supporting the start-up of parenteral manufacturing operations at the Alzey site. This includes quality oversight of project delivery, process development, operational readiness, start up, and validation/qualification of the parenteral process including dispensing, equipment preparation, formulation, filling and visual inspection. This individual is responsible for process development, operational readiness, qualification, and validation of the facility and its associated equipment. The Associate Director will help build a strong quality culture at the site and lead the QA team ensuring robust oversight and support of the ongoing operation as well as the site inspection readiness agenda.

BASIC REQUIREMENTS

• Bachelor’s degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
• Minimum 7 years’ experience in pharmaceutical leadership with QA experience, including leading or working effectively with a cross-functional group
• Minimum 7 years’ experience directly supporting parenteral manufacturing operations
• Fluent in English and German
• On-site presence required

ADDITIONAL SKILLS/PREFERENCES:

• Strong knowledge of Quality Management Systems and applicable regulatory requirements
• Previous regulatory inspection readiness and inspection execution experience
• 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 parenteral manufacturing including contamination control, environmental monitoring, aseptic process simulation, cleaning and sterilization validation, isolator technology, visual inspection
• Previous experience with Manufacturing Execution Systems and electronic batch release
• Previous experience with deviation and change management systems including Trackwise or Veeva
• 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

• 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.
• Support the site to ensure a safe work environment including supporting and leading safety efforts for the quality team.
• Support the development of the overall site operational readiness plan including development of quality processes and approval of parenteral operational procedures.
• Build a diverse and capable site organization to provide 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.
• Supervise, coach, and aid in development, performance management, ensure a fair and equitable work environment.
• Engage team and delegate to achieve results through others to deliver according to plan.
• Manage multiple priorities in a fast-paced environment and deliver in accordance with established due dates.
• Demonstrate flexibility with quick response as priorities change or issues arise.
• 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.
• Review and approve GMP documentation including qualification/validation protocols and reports, procedures, deviations, technical reports, change controls, etc. for DAP operations.
• Network with global and other parenteral sites to understand best practices, share knowledge.
• Work cross-functionally with the area process teams/flow team for metrics reviews, operational support, and issue/deviation management.
• Set area human resource and business plan goals.
• Participate in tactical and strategic business planning.
• Communicate on project and production status.
• Define, lead and/or support inspection readiness activities for operations and interact with Regulatory agencies during inspections.