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About the Role

As the central quality contact for Elanco Marketing Affiliate organizations in Japan, the Quality Senior Associate advises, decides, reports, consults, and escalates quality matters relating to Elanco products distributed in Japan to affiliate management, Head of Quality Japan, Regional Affiliate Quality Director, or Corporate management when needed.

Responsibilities

• Be responsible for product quality related matters.
• Escalate any local product quality related issue to the Head of Quality Japan, Regional Affiliate Quality Director and the Affiliate management.
• Collaborate in any local action to be taken as a result of a product quality issue (i.e. recall, counterfeit etc.).
• Implement and monitor product quality systems and Product Quality Manual in the Marketing Affiliate.
• Assist affiliate management and Head of Quality Japan in assuring that all operations of the affiliate comply with the Affiliate Quality Manual and other applicable company quality standards, GQP and local regulations.
• Execute the assessment plan for GMP Service Providers.
• Revise Quality agreement covering affiliate process for GMP service providers.
• Demonstrate continuous improvement and minimize risk by a routine self-assessment, corrective and preventative actions (CAPA), and use of a Quality Plan.
• Ensure an affiliate training program for employees with quality duties and responsibilities is in place.
• Be responsible for product complaints related matters.
• Investigate any product complaints and responses for the customer for all distributed products.

Requirements

• Registered pharmacist with bachelor’s degree or higher.
• At least 3 years’ Quality experience in a GMP/GQP environment.
• Fluent English (written and oral).
• Native level of Japanese.

Skills

• SAP system experience
• Self-managed
• Cross functional collaboration and teamwork skills

Location

• Elanco Japan Tokyo office

Work Type

• Hybrid

Experience Level

• Senior Associate
• At least 3 years’ Quality experience

Education Level

• Bachelor’s degree or higher
• Registered pharmacist

About the Company

• Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole.
• With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities.
• At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet.
• Learn more at www.elanco.com.

Equal Opportunity

• 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.