Your role
To ensure that 3rd Party Manufacturers and Logistics Service Providers (LSPs) are effective and compliant with the relevant regulatory and internal requirements, thereby ensuring that the veterinary medicinal and biocidal products released onto the market are fit for their intended purpose.
To drive and maintain improvements in the quality systems and processes related to 3rd party manufacturers, suppliers and logistic service providers.
To provide advice on all quality and compliance matters to ensure retention of the Product and Distribution Licenses.
Your responsibilities
- Support the qualification and onboarding of Third Parties and Logistics Service Providers in line with GMP/GDP and global quality standards.
- Provide quality input for product launches, qualification, and validation activities.
- Manage and support change controls with external partners and internal stakeholders.
- Support regulatory submissions and GDP inspections.
- Maintain and implement Quality Agreements with suppliers and logistics partners.
- Monitor supplier and LSP performance metrics to proactively identify compliance risks.
- Support investigations, CAPAs, and quality issue resolution with Third Parties.
- Coordinate audits and follow-up actions with suppliers and logistics providers.
- Review Product Quality Reviews (PQRs/APRs) and monitor quality trends.
- Drive continuous improvement initiatives across quality systems and supplier oversight activities.
What You Need to Succeed (minimum qualifications)
- Degree in Science (Diploma, Master’s degree or equivalent) or minimum 10 years equivalent experience in GMP role.
- Minimum 5 years’ experience in Quality Assurance within Distribution GDP regulated environments.
- Strong knowledge of GMP, GDP, and regulatory requirements for medicinal products.
- Experience working with external manufacturers, suppliers, or distribution partners.
- Experience within a global organisation and cross-functional environment.
- Excellent communication skills and strong command of English.
What will give you a competitive edge (preferred qualifications)
- Additional language skills.
- Knowledge of Quality Control processes.
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.
#J-18808-Ljbffr…