Quality Control Director

Elanco • Fort Dodge, IA

18d

About The Position

Elanco is hiring a Quality Control Director to provide administrative and technical leadership to Quality Control teams overseeing Chemistry, Virology, Immunochemistry, and other laboratory functions. The role manages quality control operations to ensure compliance with corporate and regulatory requirements while supporting internal departments and external partners.

The Director provides quality oversight to the Quality Department and site, including documentation practices, change management, sample control, laboratory systems, and investigations. The role also supports audit responses, oversees CAPA completion, develops SOPs and training programs for sample control and accountability, and identifies and mitigates risks to laboratory processes and analytical test methods. The position oversees investigations involving chemical and immunochemical assays, including employee training, review of reports for scientific and regulatory compliance, and cross-functional root cause analysis and CAPA development. The role supervises five subordinates, including a Manager Quality Control 1.

Requirements

• Master’s degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or a related field, or foreign equivalent.
• At least 3 years of post-baccalaureate experience in the offered job or a related quality control role.
• At least 3 years of experience working in a regulated pharmaceutical or vaccine manufacturing environment.
• At least 3 years of experience with regulatory requirements, including 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 CAPA, including in support of audit responses.
• At least 3 years of experience preparing and monitoring departmental budgets and ensuring adherence to them.
• At least 3 years of experience with Lean, 5S, or Six Sigma methodologies.
• At least 3 years of experience in laboratory control operations.
• At least 3 years of experience developing and maintaining SOPs 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, including 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.
• 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, high-performing laboratory environment.
• Oversee investigations involving chemical and immunochemical assays, ensuring employee training, reviewing reports for scientific and regulatory compliance, and facilitating cross-functional root cause analysis and CAPA development.
• Supervise five subordinates, including Manager Quality Control 1.

What This Job Offers

• Job Type: Full-time
• Career Level: Director