Quality Control Director

Elanco; Fort Dodge (IA); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Quality leadership

Regulatory compliance

CAPA investigations

Risk assessment

Project management

Formazione

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

Descrizione del lavoro

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better.

Your day-to-day will include:

• Provide both administrative and technical leadership to Quality Control teams overseeing Chemistry, Virology, Immunochemistry, and other key laboratory functions.
• Manage all quality control operations, to ensure full compliance with corporate and regulatory requirements while effectively 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 Action (CAPA).
• Develop and maintain Standard Operating Procedures (SOPs) and training programs related to sample control and accountability.
• Proactively identify and mitigate risks to quality control processes, including analytical chemistry and biochemistry test methods, ensuring their ongoing maintenance, validation, and improvement.
• Implement process improvements to maintain a high-performing, 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 CAPA development.
• Supervises 5 subordinates – Manager Quality Control 1.

You have the following technical skills and qualifications:

• Requirement – Master’s degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or related, or foreign equivalent plus 3 years post-baccalaureate experience in job offered or any related quality control related job titles.
• Relevant experience – Applicants must possess at least 3 years of experience in the following: (1) Working in a regulated pharmaceutical/vaccine manufacturing environment; (2) regulatory requirements, inclusive of cGMP/GLP and ensuring compliance with documentation practices, change management, and sample control; (3) Investigation techniques including providing technical guidance, training, and oversight for testing vaccines in a Vaccine manufacturing environment; (4) Conducting root cause analysis and identifying, developing, and tracking Corrective and Preventive Actions (CAPA), including in support of audit responses; (5) preparation, monitoring, and adherence of departmental budgeting; (6) Lean/5S/six sigma methodologies; (7) laboratory control operations; and (8) Developing and maintaining Standard Operating Procedures (SOPs) and validating, maintaining, and improving analytical chemistry and biochemistry test methods.

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.