Responsible Person (RP), Quality

Your Role: Responsible Person (RP), Quality

The purpose of this position is to provide final approval for filled product serials at the Elanco Fort Dodge vaccine site and submit to USDA for release to US market. This position will provide oversight of Quality Assurance processes ensuring all manufacturing, sampling, and testing activities comply with regulatory authority regulations, associated outlines of production and Elanco standards, as well as technical guidance, training, and oversight regarding Quality and GMP for the site. Responsible Person is responsible for identifying and implementing new quality initiatives, systems, and strategies to drive continuous improvement and innovation to sustain compliance and competitive advantage.

Your Responsibilities:

• Provide oversight of Quality Assurance processes ensuring all manufacturing, sampling, and testing activities comply with regulatory authority regulations, associated outlines of production and Elanco standards.

• Ensure product quality and compliance with regulatory requirements for released batches through review and assessment of batch documentation, analytical data, and associated deviations, change controls and CAPA.

• Implement SOPs to align with current regulations, Elanco Global Quality Standards and Elanco Functional Procedures.

• Assist with internal, regulatory, or corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents.

• Provide training and guidance to personnel relating to GMP principles, quality procedures, and regulatory requirements.

What You Need to Succeed (minimum qualifications):

• Bachelor’s Degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or Engineering.

• 10 years in a regulated pharmaceutical /vaccine manufacturing environment.

• ​Thorough understanding of the principles and methods of vaccine manufacturing and formulation, sterility assurance, Quality Control testing and analysis, packaging, storage, and distribution.

• Must demonstrate ability to work and communicate with diverse groups across the organization at all levels on a routine basis, locally and globally.

• Well versed in all regulatory requirements, inclusive of cGMP/GLP

• Significant working and theoretical knowledge are required to objectively assess procedures and determine the level of compliance, apply appropriate risk assessment, and recommend improvements to improve compliance levels.

What Will Give You the Competitive Edge (preferred qualifications):

• Ability to work and communicate with diverse groups across the organization at all levels on a routine basis, locally and globally.

• Good knowledge of statistics, databases, and quality principles.

• Makes routine decisions with limited guidance from management.