Director of Quality Control & Regulatory Excellence

Iowa Ag; Fort Dodge (IA); On-site; USD 120,000 - 150,000; Full time

Job summary

Elanco, a global animal health leader, seeks a Quality Control Director to oversee chemistry, virology, and immunochemistry QA operations in Fort Dodge, IA. You will ensure compliance with cGMP/GLP, manage CAPA responses, and drive SOP development and training.

The role requires a Master’s in a relevant field and at least 3 years in a regulated pharma environment, with strong leadership and budgeting skills to support audits and continuous improvement.

Qualifications

• Master's degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or related field plus 3 years experience in a regulated pharma environment.
• Experience with cGMP/GLP, documentation practices, change management, and sample control.
• Proven ability to lead QA teams, investigate root causes, and develop CAPA actions.

Responsibilities

• Provide administrative and technical leadership to Quality Control teams overseeing chemistry, virology, immunochemistry, and other lab functions.
• Ensure QA operations comply with corporate and regulatory requirements; support internal departments and external partners.
• Develop and maintain SOPs; lead CAPA investigations and cross-functional root-cause analysis.

Skills

Lean/Six Sigma

CAPA oversight

Education

Master's degree in Biology/ Chemistry/ Biochemistry/ Biopharmaceuticals (or related)

Tools

SOP writing

Job description

Elanco, a global animal health leader, seeks a Quality Control Director to oversee chemistry, virology, and immunochemistry QA operations in Fort Dodge, IA. You will ensure compliance with cGMP/GLP, manage CAPA responses, and drive SOP development and training.

The role requires a Master’s in a relevant field and at least 3 years in a regulated pharma environment, with strong leadership and budgeting skills to support audits and continuous improvement.