Senior Director, Quality Control & Compliance

Elanco; Fort Dodge (IA); On-site; USD 90,000 - 120,000; Full time

Job summary

Elanco is seeking a Quality Control leader in the Fort Dodge, IA area. The role focuses on administrative and technical leadership of QA teams across Chemistry, Virology and Immunochemistry, ensuring compliance and robust quality systems.

The position requires a Master’s degree and 3+ years in a regulated pharma setting, with expertise in cGMP/GLP, CAPA, and SOP development. A strong emphasis on training, change control, and risk mitigation is essential for maintaining high-quality lab

Qualifications

• Master’s degree or foreign equivalent plus 3 years post-baccalaureate experience in quality control or related titles.
• Experience in regulated pharmaceutical/vaccine manufacturing environments.
• Knowledge of cGMP/GLP, documentation, change management and sample control.

Responsibilities

• Provide administrative and technical leadership to Quality Control teams.
• Manage quality control operations ensuring compliance with corporate and regulatory requirements.
• Oversee documentation practices, change management, sample control, lab systems, and investigations.
• Support CAPA and audit responses; ensure timely completion.
• Develop and maintain SOPs and training related to sample control and accountability.
• Identify and mitigate risks to QA processes and test methods; maintain and improve analytical methods.
• Oversee investigations of chemical and immunochemical assays and CAPA development.
• Supervise 5 subordinates – Manager Quality Control 1.

Skills

Quality leadership

Regulatory compliance

CAPA investigations

Risk assessment

Project management

Education

Master’s degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or related

Job description

Elanco is seeking a Quality Control leader in the Fort Dodge, IA area. The role focuses on administrative and technical leadership of QA teams across Chemistry, Virology and Immunochemistry, ensuring compliance and robust quality systems.

The position requires a Master’s degree and 3+ years in a regulated pharma setting, with expertise in cGMP/GLP, CAPA, and SOP development. A strong emphasis on training, change control, and risk mitigation is essential for maintaining high-quality lab