Sr. Director, Quality

Role Summary

Senior Director, Site Quality responsible for providing 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 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. Final approval for testing, inspection, and release of materials 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 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 regulatory compliance and educating the workforce on quality and compliance topics.
• Quality Systems Implementation & Issue Resolution: Leads implementation of quality policies, systems, and procedures to assure product purity, efficacy, safety, and potency; ensures robust root cause investigations and CAPAs for quality and compliance issues.
• Regulatory Compliance & Business Partnership: Serves as site leader for regulatory inspections, ensuring compliance with requirements for product quality and right to operate; partners with internal and external entities on quality and compliance matters related to current products, launches, and worldwide approvals.

Qualifications

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

Skills

• Strategic leadership in quality, compliance, and QA/QC
• Biotech manufacturing and process validation
• Regulatory inspections and audit readiness
• Quality systems, CAPA management, and root cause analysis
• Cross-functional collaboration and stakeholder management

Education

• Bachelor’s degree (required as listed in Qualifications)

Additional Requirements

• Location: Elwood, Kansas; on-site with relocation package