Sr. Director, Quality

Role Summary

Senior Director, Site Quality. This role provides technical, regulatory/compliance, and strategic leadership for the Quality function at the Elwood, KS site, accountable for all Product Quality, Compliance and Quality System activities, as well as development, launch and commercialization of new products in collaboration with Elanco R&D and other functions.

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. 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 on quality and compliance matters related to current products, product launches, and worldwide production/distribution approvals.

Qualifications

• Education: Bachelor‚Äôs degree in Chemistry, Bio/Pharmaceutical Technology, Microbiology, or related discipline.
• Experience: 10+ years in pharmaceutical and/or vaccine/biotech production; 5+ years in people management (direct & indirect reports).
• Thorough knowledge of cGMP regulatory requirements for Biotech products, including direct experience with external audits (USDA, FDA, EMEA).
• Previous experience building a Quality Culture and developing high-functioning teams

Skills

• Regulatory inspections and compliance management
• Strategic planning and leadership
• Quality systems and CAPA management
• Cross-functional collaboration and stakeholder management
• Biotech manufacturing processes and QA/QC oversight

Education

• Bachelor‚Äôs degree in Chemistry, Bio/Pharmaceutical Technology, Microbiology, or related discipline

Additional Requirements

• Location: Elwood, Kansas (On-Site). Relocation package available.