Quality Control Director

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.

Your day-to-day will include:

• Provide both administrative and technical leadership to Quality Control teams overseeing Chemistry, Virology, Immunochemistry, and other key laboratory functions.
• Manage all quality control operations, to ensure full compliance with corporate and regulatory requirements while effectively supporting internal departments and external partners.
• Provide quality oversight to the Quality Department and site, ensuring compliance with documentation practices, change management, sample control, laboratory systems, and laboratory investigations.
• Support audit responses and ensure timely completion of assigned Corrective and Preventive Action (CAPA).
• Develop and maintain Standard Operating Procedures (SOPs) and training programs related to sample control and accountability.
• Proactively identify and mitigate risks to quality control processes, including analytical chemistry and biochemistry test methods, ensuring their ongoing maintenance, validation, and improvement.
• Implement process improvements to maintain a high-performing, efficient laboratory environment.
• Oversee quality control investigations involving chemical and immunochemical assays by ensuring employee training, reviewing reports for scientific and regulatory compliance, and facilitating cross-functional root cause analysis and CAPA development.
• Supervises 5 subordinates – Manager Quality Control 1.

You have the following technical skills and qualifications:

• Requirement – Master’s degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or related, or foreign equivalent plus 3 years post-baccalaureate experience in job offered or any related quality control related job titles.
• Relevant experience – Applicants must possess at least 3 years of experience in the following: (1) Working in a regulated pharmaceutical/vaccine manufacturing environment; (2) regulatory requirements, inclusive of cGMP/GLP and ensuring compliance with documentation practices, change management, and sample control; (3) Investigation techniques including providing technical guidance, training, and oversight for testing vaccines in a Vaccine manufacturing environment; (4) Conducting root cause analysis and identifying, developing, and tracking Corrective and Preventive Actions (CAPA), including in support of audit responses;
  
  (5) preparation, monitoring, and adherence of departmental budgeting; (6) Lean/5S/six sigma methodologies; (7) laboratory control operations; and (8) Developing and maintaining Standard Operating Procedures (SOPs) and validating, maintaining, and improving analytical chemistry and biochemistry test methods.

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,…