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

• Batch Release:

  • Provide disposition decisions for APIs, packaging materials, intermediates, and finished products

• Stability:

  • Manage and monitor internal stability programs

  • Provide oversight of stability programs conducted at contract manufacturers

• Product Quality Review (PQR):

  • Manage the PQR program as required

  • Review data for trends, emerging issues, and risks, and define corrective or preventive actions

  • Collaborate closely with contract manufacturers, regulatory affairs, technical services, and quality teams to compile and complete PQR documentation

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