Summary

Elanco Animal Health Incorporated is a global leader in the animal health pharmaceutical industry, dedicated to improving the health and well-being of both pets and farm animals worldwide. Founded in 1954 as a division of Eli Lilly and Company, Elanco became an independent public company in 2018 and has since grown to become the world's second-largest independent animal health company. With approximately 9,000 employees globally, the company operates with a clear purpose: 'making life better for animals, makes life better.' Elanco develops innovative medicines, vaccines, and health solutions that empower veterinarians, farmers, and pet owners to advance animal care. The company maintains a balanced portfolio between pet health and farm animal products, offering over 200 brands that address critical health challenges ranging from companion animal diseases to livestock productivity. Headquartered in Indianapolis, Indiana, Elanco is publicly traded on the New York Stock Exchange (NYSE: ELAN) and continues to drive innovation in animal health through strategic acquisitions and dedicated research and development efforts.

Job description

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.

Requirements

Master’s degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or related, or foreign equivalent
3 years post-baccalaureate experience in job offered or any related quality control related job titles
At least 3 years of experience working in a regulated pharmaceutical/vaccine manufacturing environment
At least 3 years of experience with regulatory requirements, inclusive of cGMP/GLP and ensuring compliance with documentation practices, change management, and sample control
At least 3 years of experience with investigation techniques including providing technical guidance, training, and oversight for testing vaccines in a Vaccine manufacturing environment
At least 3 years of experience conducting root cause analysis and identifying, developing, and tracking Corrective and Preventive Actions (CAPA), including in support of audit responses
At least 3 years of experience with preparation, monitoring, and adherence of departmental budgeting
At least 3 years of experience with Lean/5S/six sigma methodologies
At least 3 years of experience with laboratory control operations
At least 3 years of experience developing and maintaining Standard Operating Procedures (SOPs) and validating, maintaining, and improving analytical chemistry and biochemistry test methods

Company overview

Elanco Animal Health Incorporated is a global leader in the animal health pharmaceutical industry, dedicated to improving the health and well-being of both pets and farm animals worldwide. Founded in 1954 as a division of Eli Lilly and Company, Elanco became an independent public company in 2018 and has since grown to become the world's second-largest independent animal health company. With approximately 9,000 employees globally, the company operates with a clear purpose: 'making life better for animals, makes life better.' Elanco develops innovative medicines, vaccines, and health solutions that empower veterinarians, farmers, and pet owners to advance animal care. The company maintains a balanced portfolio between pet health and farm animal products, offering over 200 brands that address critical health challenges ranging from companion animal diseases to livestock productivity. Headquartered in Indianapolis, Indiana, Elanco is publicly traded on the New York Stock Exchange (NYSE: ELAN) and continues to drive innovation in animal health through strategic acquisitions and dedicated research and development efforts.