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Your Role: Senior Associate - QA
As the central quality contact for the Elanco Marketing Affiliate organizations (Japan), the Quality Senior Associate advises, decides reports, consults and escalates quality matters relating to Elanco products distributed in Japan, to the affiliate management, Head of Quality Japan, Regional Affiliate Quality Director or Corporate management when needed.
Your 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, and collaborate in any local action to be taken as a result of that (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, responses for the customer all distributed products.
What You Need to Succeed (minimum qualifications):
Education: Registered pharmacist with bachelor’s degree or higher
Experience: At least 3 years’ Quality experience in a GMP/GQP environment.
Communication: Fluent English (written and oral), Native level of Japanese
What will give you a competitive edge (preferred qualifications):
SAP system experience
Self-managed
Cross functional collaboration and teamwork skills
Additional Information:
Travel: 10%
Location: Elanco Japan Tokyo office - Hybrid Work Environment
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
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.
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