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. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.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!<div><div>Your Role: Director, Quality Operations </div><div>The purpose of this position is to provide administrative and technical direction to Quality Operations team at the Fort Dodge site. Scope of Quality oversight includes all manufacturing and HUB operations: incoming inspection, material storage and handling, seed/cells, fermentation, downstream, blending, filling, packaging, labeling, product release, and supplier quality. </div><div> </div><div>This position ensures that quality products are released to market through proper selection and training of staff, maintaining compliance within the department and site. </div><div> </div><div>Director, Quality Operations is responsible for identifying and implementing new quality initiatives, systems, and strategies to drive continuous improvement and innovation to sustain compliance and competitive advantage. </div><div> </div><div>You Responsibilities: </div><div><ul><li>Implements SOPs to align with current regulations, Elanco Global Quality Standards and Elanco Functional Procedures.  </li><li>Assist with internal, regulatory or corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents.  </li><li>Provides routine quality oversight of manufacturing operations through floor audits, line checks, and routine walkthroughs, coordinates with manufacturing operations for reporting and resolution of manufacturing issues via the event reporting system and collaborates with manufacturing operations and microbiology department in identifying contamination risks and implementing control strategies. </li><li>Provides oversight of the management, training, and qualification of employees performing critical in-process or finished product release functions, while proactively identifying areas of improvement with Good Documentation practices and leading site initiatives to improve compliance of manufacturing records. </li><li>Owner of incoming raw material, packaging, and consumable specifications and provides oversight of the site incoming quality inspection program, finished goods batch release, and material handling, storage and control. </li><li>Coordinates with procurement, R&D and site operations in the selection and approval of new suppliers, coordinates with EGQCA in the development of the annual supplier audit plan and Tracks supplier audit responses and completion of associated CAPA. </li><li>Identifies required curricula for Quality Operations team and performs annual reviews of training curricula </li><li>Writes or reviews Quality department investigations to ensure compliance to procedural requirements, identification of root cause and implementation of effective CAPA. </li></ul></div><div> </div><div>What You Need to Succeed (Minimum Qualifications): </div><div><ul><li>Bachelor's degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, Business Administration, Economics, Engineering, IS/IT or related field. </li><li>Minimum of 10 years' experience in a regulated pharmaceutical /vaccine manufacturing environment.   </li><li>Must demonstrate ability to work and communicate with diverse groups (production, engineering, maintenance, planning, etc.) across the organization at all levels on a routine basis, locally and globally.  </li><li>Significant working and theoretical knowledge are required to objectively assess procedures and determine the level of compliance, apply appropriate risk assessment, and recommend improvements to improve compliance levels.  </li><li>Experience in department oversight (organizational, budgeting, strategy) required. </li></ul></div></div><div><div> </div><div>What Will Give You a Competitive Edge (Preferred Qualifications): </div><div><ul><li>Good knowledge of statistics, databases, and quality principles. </li><li>Demonstrates proficiency in lean/5S/six sigma methodologies </li><li>Ability to plan, schedule, organize, prioritize, and coordinate project activities. </li><li>Written and verbal communication with cross-functional groups. </li></ul></div><div>Don’t meet every single requirement?  Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! </div><div>Elanco Benefits and Perks: We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:</div><div><ul><li>Multiple relocation packages </li><li>Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO) </li><li>8-week parental leave </li><li>9 Employee Resource Groups </li><li>Annual bonus offering </li><li>Flexible work arrangements </li><li>Up to 6% 401K matching </li></ul></div><div> </div></div>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 <img src="https://ars2.equest.com/? response_id=3147839a5bb1edcda08fa78bb21efd8d&view" alt=" " width="1" height="1"/>

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