Manager, Quality Assurance

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.

We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

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: Manager, Quality Assurance

As a QA Manager, you will be part of the Quality team to deliver a high-performing QA batch review/release team.

In this role, you’ll be responsible for providing technical direction, mentoring and developing the team, and fostering a culture of quality.

Your Responsibilities:


* Oversee Quality Assurance Product Release: This includes approving, controlling, and securing master data, procedures, records, and reports at the Fort Dodge site.

Focus on achieving Right First Time (RFT) metrics for batch releases, Manufacturing Directions (MDs), and USDA/CVB 2008 submissions.

Oversee Standard Operating Procedure (SOP) revision, review, and approval.


* Manage Quality Systems: Act as the site master data steward for all controlled quality documents.

Conduct monthly and 7-day reviews of Approved Outlines of Production (AORs).

Complete impact assessments for change control that impact product release.


* Drive Continuous Improvement and Compliance: Identify and implement quality initiatives, systems, and strategies for continuous improvement and compliance.

Share successful programs with other Elanco sites.


* SAP and System Administration: Oversee aspects of SAP related to expiration date extensions, batch header setup, material change requests, inspection lot assignments, user access, annual user access review, and supply chain data updates.

Assess data integrity gaps.

Manage User Access/Account setup and maintenance for TABS Administrator, conduct periodic reviews, annual access/security reviews, and annual audit trail reviews.


* Leadership and Team Management: Provide technical guidance, training, and oversight for the department.

Facilitate weekly huddles and conduct mid-year and end-of-year reviews with direct reports.

Monitor schedules for the review/release team.

Maintain the release schedule to ensure timely completion of two-week lock scheduling initiatives.

Participate in weekly scheduling meetings and monitor the review/release backlog.

What You Need to Succeed (minimum qualifications):
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