Animal Care, Artificial Intelligence (AI), Change Control, Change Management, Code of Federal Regulations, Communication Skills, Construction Design, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cost Control, Cross-Functional, Disease Prevention and Control, Diversity, Document Management, FDA (Food and Drug Administration), Leadership, Lean Manufacturing, Maintain Compliance, Manufacturing, Manufacturing Methods, Operations Management, Process Improvement, Project/Program Management, Quality Assurance, Quality Management, Quality Metrics, Root Cause Analysis, Safety Standards, Service Delivery, Six Sigma, Standard Operating Procedures (SOP), Statistical Process Control, Technical Leadership, Time Management, United States Department of Agriculture (USDA)
At Elanco (NYSE: ELAN) - it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better - join our team today!
Your Role: Process Change & CAPA Lead
As the Process Change & CAPA Lead, you will be part of a dedicated process team to deliver end-to-end lifecycle management of change controls and Corrective and Preventive Actions (CAPAs). In this role, you'll be responsible for providing technical leadership for process and equipment modifications while ensuring full regulatory compliance and operational efficiency.
Your Responsibilities:
- Serve as the primary owner for the initiation, technical leadership, and timely completion of all change controls, CAPAs, and Master Production Record (MPR) updates.
- Lead process deviations and quality events by performing robust root cause analysis and implementing effective corrective/preventative actions to prevent recurrence.
- Drive continuous improvement by identifying cost-effective process enhancements and participating in the Site Value Office committee.
- Collaborate cross-functionally with Operations, Engineering, HSE, and Quality Assurance to ensure alignment on project goals and safety standards.
- Act as a technical liaison for external contractors and vendors while ensuring on-floor practices match documented quality standards.
What You Need to Succeed (minimum qualifications):
- Education: Bachelor's Degree in a relevant field or equivalent level of experience.
- Experience: A minimum of 4-6 years of relevant experience in change management, quality systems, or process support within a manufacturing environment.
- Top 2 skills: Project management (including design, construction, and qualification) and excellent technical communication/SOP writing.
What will give you a competitive edge (preferred qualifications):
- Knowledge of the principles and guidelines of CFR 9 and the USDA.
- Experience using Veeva Systems for quality and document management.
- Preferred experience with process support in a regulated industry (e.g., FDA, USDA, EMA).
- Expertise in Statistics and Statistical Process Control (SPC) capability.
- Demonstrated leadership capabilities and experience in Lean Manufacturing techniques (e.g., Six Sigma).
Elanco 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
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.