Quality Control Director

## Quality Control Director Apply:
Fort Dodge, IA:
Full time:
Posted Today:
R0027618
** 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 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…