Quality Assurance Manager – US Marketing Affiliate

Role Summary

Quality Assurance Manager – US Marketing Affiliate. You will provide technical leadership and day-to-day quality oversight across affiliate operations to maintain compliance throughout the product supply chain, support product launches, and collaborate cross-functionally to drive quality excellence. You will lead a small team and represent US Affiliate Quality across the Global Quality network with responsibility for product approval and affiliate compliance.

Responsibilities

• Lead US Affiliate quality oversight by managing a small team responsible for ensuring compliant product supply for the US market and acting as a key driver of quality excellence.
• Own accountability for product approval for distribution in the US market, ensuring product readiness and compliance prior to release.
• Resolve routine operational and technical issues using a risk-based approach, including batch approvals, SAP transactions, storage/distribution oversight, and shipments across affiliate warehouses and to customers.
• Ensure end-to-end compliance with GxP standards and internal procedures by maintaining current, fit-for-purpose local quality procedures aligned with global standards and US regulatory requirements.
• Drive continuous improvement and compliance management across affiliate and third-party operations, including deviation/CAPA management, change controls, quality complaints, returned product assessments, self-inspections, third-party quality oversight, and escalation/impact assessments for failures affecting safety or recall risk.

Qualifications

• Education: Bachelor’s degree in chemistry, pharmacy, engineering, or related scientific field required, or equivalent work experience
• Required Experience: Minimum 5 years of pharmaceutical Quality Assurance experience, including strong working knowledge of Good Practices for storage, distribution, and documentation (manufacturing familiarity preferred)
• Top 2 skills: GxP Quality & compliance leadership (deviations/CAPA/change control/complaints/inspections) + Risk-based problem solving and cross-functional communication

Education

• Bachelor’s degree in chemistry, pharmacy, engineering, or related scientific field required, or equivalent work experience

Additional Requirements

• Travel: Less than 10% (planned travel; minimal emergency/unplanned travel)
• Location: Global Elanco Headquarters – Indianapolis, IN – Hybrid Work Environment