Quality Control Director

Elanco • Fort Dodge, IA

20d

About The Position

Elanco is seeking 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 laboratory investigations. The position supports audit responses and timely completion of assigned Corrective and Preventive Actions (CAPA), and develops and maintains SOPs and training programs for sample control and accountability.

The role identifies and mitigates risks to quality control processes, including analytical chemistry and biochemistry test methods, and oversees their maintenance, validation, and improvement. It also implements process improvements and oversees investigations involving chemical and immunochemical assays, including employee training, scientific and regulatory review of reports, cross-functional root cause analysis, and CAPA development. The position supervises five subordinates, identified as Manager Quality Control 1.

Requirements

• Master’s degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or a related field, or 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 cGMP/GLP and 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 testing vaccines in a vaccine manufacturing environment.
• At least three years of experience conducting root cause analysis and identifying, developing, and tracking CAPA, including in support of audit responses.
• At least three years of experience preparing, monitoring, and adhering to departmental budgets.
• At least three years of experience with Lean, 5S, or Six Sigma methodologies.
• At least three years of experience in laboratory control operations.
• At least three 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 and support internal departments and external partners.
• Provide quality oversight to the Quality Department and site for documentation practices, change management, sample control, laboratory systems, and laboratory investigations.
• Support audit responses and ensure timely completion of assigned CAPA.
• Develop and maintain 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 ongoing maintenance, validation, and improvement of those methods.
• Implement process improvements to maintain a high-performing, efficient laboratory environment.
• Oversee quality control investigations involving chemical and immunochemical assays, including employee training, report review for scientific and regulatory compliance, and cross-functional root cause analysis and CAPA development.
• Supervise five subordinates, identified as Manager Quality Control 1.

What This Job Offers

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