Manager, Quality Assurance (Project Management)
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):
Bachelor's Degree or equivalent level of experience.
A minimum of 5 years of experience in Quality or equivalent
What will give you a competitive edge (preferred qualifications):
Demonstrated leadership skills, including the ability to inspire and motivate a team, delegate effectively, and manage performance.
Strategic thinking and planning skills, with the ability to align quality initiatives with overall business objectives.
Experience developing and implementing quality metrics and KPIs to drive performance improvement.
Proactive approach to identifying and mitigating quality risks.
Prior experience with regulatory inspections and audits.
Additional Information:
Location: Fort Dodge, IA
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Up to 6% 401K matching
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
