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 Consultant
As a Quality Consultant, you will provide independent quality oversight of Contract Manufacturers (CMs) across the Asia Pacific region. In this role, you will be responsible for ensuring that manufactured products comply with market authorisations for local and global markets, while proactively managing risks related to product quality, GMP compliance, and animal safety.
You will work closely with internal and external stakeholders to support batch release, stability programs, product quality reviews, and quality event management, primarily supporting the Australia and New Zealand markets.
Your Responsibilities:
Quality Governance of Contract Manufacturers and Products
Provide quality oversight of contract manufacturers, including recommending and supporting quality improvement initiatives
Ensure Quality/Technical Agreements are in place with all contract manufacturers and that joint problem-tracking (JPT) processes are implemented for quality or GMP deficiencies
Participate in inspections and audits of contract manufacturers, including follow-up and verification of corrective actions
Complete annual contract manufacturer risk assessments
GMP Documentation & Data Integrity
Develop, review, and approve internal GMP procedures and quality documentation
Review and approve GMP documentation from contract manufacturers related to assigned products
Ensure records are retained in accordance with local and global requirements
Ensure data integrity through second-person verification and/or validated computerized systems
Review and assess data integrity practices at contract manufacturers to ensure compliance with company standards
Quality Management: Batch Release, Stability & PQR
Event Management (Changes, Deviations, Complaints)
Manage change control, deviations, and complaint systems, ensuring timely investigation, documentation, and closure
Participate in change control and deviation review meetings, including review and approval of internal and external events
Additional Responsibilities
Collect and report Quality Monthly Metrics
Provide end-user training as a Power User when required
Adhere to company policies related to finance, HSE, and compliance
Participate in operational excellence initiatives
What You Need to Succeed (Minimum Qualifications)
Education: Tertiary qualification in Science or a related discipline
Experience: Minimum of 5 years’ QA/QC experience in a GMP-regulated environment
Top Skills: Strong GMP knowledge combined with analytical, investigative, and decision-making capability
What Will Give You a Competitive Edge (Preferred Qualifications)
Prior experience or exposure within the Animal Health industry
Strong analytical and problem-solving skills
Excellent written and verbal communication skills
Ability to manage multiple priorities and work independently
Proven ability to collaborate effectively with cross-functional internal and external stakeholders
Proficiency in MS Office and SAP systems
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 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
