Sr. Director, Quality

Senior Director, Site Quality

Reporting to the Biotech Global Quality Leader, with dotted-line reporting to the Site Head, this role is responsible for providing technical, regulatory / compliance, and strategic leadership for the Quality function at the Elwood, KS site. The leader is accountable for all Product Quality, Compliance and Quality System activities as well as for the development, launch, and commercialization of new products in collaboration with Elanco R&D and other relevant functions.

Your Responsibilities :

• Strategic Quality Leadership & Continuous Improvement : Provides strategic leadership and oversight for Quality Assurance, Compliance, and Quality Control testing, driving continuous improvement through a robust Quality Plan and collaboration with the Site Leadership Team. This includes final approval for testing, inspection, and release of materials (packaging components, raw materials, labeling) and finished products, as well as product / process validation and quality documentation. Oversees product release, recalls, and market withdrawals.
• Biotech Manufacturing Expertise Development : Develops and enhances the organization's technical capabilities in Biotech product manufacturing, including talent identification, succession planning, recruitment, and leadership of a Quality organization of approximately 20 personnel (including 7 direct reports).
• GxP Training & Education : Leads strategic planning, direction, and execution of all GxP training activities at the site, ensuring compliance with regulatory requirements and educating the workforce on relevant quality and compliance topics.
• Quality Systems Implementation & Issue Resolution : Leads the implementation of quality policies, systems, and procedures to assure product purity, efficacy, safety, and potency. Ensures robust root cause investigations and corrective actions (CAPAs) for quality and compliance issues impacting manufactured products.
• Regulatory Compliance & Business Partnership : Serves as the site leader for regulatory inspections, ensuring compliance with all requirements for product quality and right to operate. Partners with various internal and external entities (Sites under Establishment 196 licensure, Operations, Technical Services, Manufacturing Science, Marketing, R&D, Regulatory Affairs) on quality and compliance matters related to current products, product launches, and worldwide production / distribution approvals.

What You Need to Succeed (minimum qualifications) :

What will give you a competitive edge (preferred qualifications) :

Additional Information :

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.