Senior Biologics Quality & Regulatory Compliance Lead

Elanco Tiergesundheit AG; Iowa (LA); Presencial; USD 110.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Relocation packages

Parental leave (8 weeks)

Employee Resource Groups (ERGs)

Annual bonus

401(k) matching up to 6%

Descripción de la vacante

Elanco seeks a Senior Quality Advisor – Biologics Regulatory Compliance to advance quality, regulatory compliance, and commercialization across the CVB network.

You will partner with multiple sites and global teams to strengthen compliance, support new product introductions, and guide technical discussions with regulatory agencies. A strong leadership track record in biologics is essential.

Formación

• Bachelor’s degree in a life science required; advanced degrees preferred.
• Deep knowledge of USDA/FDA/EU GMP for biologics and vaccines.
• Proven ability to drive quality/compliance initiatives across sites and functions.

Responsabilidades

• Develop and execute strategic quality initiatives to strengthen regulatory compliance.
• Serve as Alternate Liaison for USDA CVB interactions and regulatory submissions.
• Collaborate with manufacturing, sterility, and global quality teams to resolve issues.

Conocimientos

Biologics manufacturing

Regulatory compliance

Cross-functional leadership

Educación

Bachelor's degree in Biochemistry, Chemistry, Biology or related field

Master's or PhD preferred

Descripción del empleo

Elanco seeks a Senior Quality Advisor – Biologics Regulatory Compliance to advance quality, regulatory compliance, and commercialization across the CVB network.

You will partner with multiple sites and global teams to strengthen compliance, support new product introductions, and guide technical discussions with regulatory agencies. A strong leadership track record in biologics is essential.