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 associates to support our growth in Alzey, Germany. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies. The Senior Associate, Quality Assurance – CAPA Lead serves as the site lead overseeing the LKC Deviation and CAPA program which is part of the overall Quality Management System (QMS) which enables the organization to provide safe and effective products and to meet customer expectations and regulatory requirements. The QA Compliance CAPA Lead is responsible for collecting and analyzing information to identify actual and potential product and quality problems, to work with the Site Quality Lead Team to take appropriate and effective corrective and preventive actions, and to verify and validate the effectiveness of those CAPA. The individual in this role will lead the site in driving product and process improvement and enhanced product and process understanding. This position is essential for maintaining GMP compliance and ensuring inspection readiness. Responsibilities: Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals. Leads, mentors, and coaches operations and support personnel on the deviation management system and CAPA program. Facilitates the Site Deviation and CAPA review board, providing board leadership to drive complete root cause investigations and ensure assignment of corrective and preventive actions to eliminate the root causes of a detected issue or other undesirable situation to prevent reoccurrence. Create and maintain the CAPA program, through working cross-functionally with all area/function owners to include data sources that identify existing as well as potential problems. Compile and present CAPA program health metrics to the Site Quality Lead Team with proposed actions. Monitor deviation and CAPA performance to ensure investigations and associated CAPA are completed in a timely manner. Act as a site instructor for Deviation Management courses. Coaches lead investigators on technical writing. Authors periodic reviews and acts as Subject Matter Expert for site CAPA and Deviation Management procedures. Supports and initiates deviations, trends, or other technical investigations, as applicable. Engages site personnel in the relationship between the CAPA program and resulting product and process improvement and enhanced product and process understanding. Works with the network deviation program mentor to benchmark and replicate best practices. Basic Requirements: Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience. Minimum 5 years in the pharmaceutical industry with specific deviation management and CAPA experience. Fluent in English and German. On-site presence required. Additional Skills/Preferences: Demonstrated understanding of cGMP regulations. Previous experience in GMP production environments. Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing Proficiency with applicable computer systems Demonstrated strong oral and written communication skills Demonstrated interpersonal skills and the ability to work as a team Root cause analysis/troubleshooting skills Demonstrated attention to detail and ability to maintain quality systems Proven ability to work independently or as part of a Team to resolve an issue Technical Writing and Communication Skills Previous regulatory inspection readiness and inspection execution experience. Additional Information: Primary location is Alzey, Germany Ability to travel (approximately 10-20 %) Ability for Short Term Assignment (6-9 Months) in a Parenteral Products Network (PPN) established manufacturing site prior to starting the role Ability to work overtime as required. 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 ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly 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. WeAreLilly