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Elanco

Global animal health pharmaceutical company

Quality Control Director

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeFort Dodge, IA, USANo salary listedIn-person

About the Job

Requirements

  • A master's degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or a related field, or a foreign equivalent, plus three years of post-baccalaureate experience in the job offered or a related quality-control job.
  • At least three years of experience working in a regulated pharmaceutical or vaccine manufacturing environment.
  • At least three years of experience with regulatory requirements, including current Good Manufacturing Practices and Good Laboratory Practices, and ensuring compliance with documentation practices, change management, and sample control.
  • At least three years of experience with investigation techniques, including providing technical guidance, training, and oversight for vaccine testing in a vaccine manufacturing environment.
  • At least three years of experience conducting root cause analysis and identifying, developing, and tracking Corrective and Preventive Actions, including in support of audit responses.
  • At least three years of experience preparing and monitoring departmental budgets and ensuring adherence to them.
  • At least three years of experience with Lean, 5S, and Six Sigma methodologies.
  • At least three years of experience in laboratory control operations.
  • At least three years of experience developing and maintaining Standard Operating Procedures and validating, maintaining, and improving analytical chemistry and biochemistry test methods.

Responsibilities

  • Provide administrative and technical leadership to Quality Control teams overseeing Chemistry, Virology, Immunochemistry, and other laboratory functions.
  • Manage quality control operations to ensure compliance with corporate and regulatory requirements while 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 Actions.
  • Develop and maintain Standard Operating Procedures and training programs related to sample control and accountability.
  • Identify and mitigate risks to quality control processes, including analytical chemistry and biochemistry test methods, and ensure their maintenance, validation, and improvement.
  • Implement process improvements to maintain an 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 Corrective and Preventive Action development.
  • Supervise five subordinates, including a Quality Control Manager.

About the Company

Elanco

Global animal health pharmaceutical company

Elanco is a global animal health company that develops and sells medicines, vaccines, and preventive care products for livestock and pets. Its portfolio includes prescription medicines, vaccines, parasite controls, and other welfare products used by veterinarians, farmers, and pet owners to prevent or treat disease and improve wellbeing. Since becoming independent after separating from Eli Lilly and acquiring Bayer Animal Health in 2020, it ranks as the world’s second-largest animal health company with a broad, globally distributed product line and direct-to-consumer capabilities. Its goal is to improve animal health and welfare worldwide by providing effective, accessible products and services while growing sustainably.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Indianapolis, IN
Founded
1954

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