Quality Assurance Manager – US Marketing Affiliate

Elanco•Indianapolis, IN

1d•Hybrid

About The Position

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today! Your Role: Quality Assurance Manager – US Marketing Affiliate As the Quality Assurance Manager – US Marketing Affiliate, you will play a pivotal role in ensuring robust quality support across US Affiliate functional areas to maintain strong compliance throughout the product supply chain through delivery to the customer. In this role, you’ll provide technical leadership and day-to-day quality oversight across affiliate operations, resolving operational issues, supporting product launches, and partnering cross-functionally to drive quality excellence. You will lead a small team and represent US Affiliate Quality across the broader Global Quality network with responsibility for product approval and affiliate compliance.

Requirements

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

Nice To Haves

Proven ability to build partnerships across functions (e.g., Regulatory Affairs, Supply Chain, Operations) to resolve quality and compliance challenges quickly and effectively
Demonstrated initiative, influence, and effectiveness on cross-functional teams, including participation in regional/global projects impacting affiliate operations
Strong attention to detail and ability to maintain high standards in documentation and procedural alignment with global quality standards
Ability to prioritize and manage multiple concurrent tasks, with strong planning, organization, and decision-making within scope
High curiosity and foresight, and ability to anticipate issues and proactively drive solutions before they impact customers, users, animal safety, or trigger recalls

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.