シニアアソシエイト(品質保証 / QA) / Senior Associate - QA

Posted 7 Days Ago
Be an Early Applicant
Tokyo, JPN
In-Office
Senior level
Healthtech • Pharmaceutical • Manufacturing
The Role
Serve as the central quality contact for Elanco Japan affiliate: manage product quality issues (complaints, recalls, counterfeits), implement and monitor quality systems and Product Quality Manual, ensure GQP/GMP and local regulatory compliance, assess and manage GMP service providers and quality agreements, lead CAPA and self-assessments, oversee affiliate quality training, and collaborate/escalate to regional or corporate quality leadership as needed.
Summary Generated by Built In

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: 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.

Skills Required

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

Elanco Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Elanco and has not been reviewed or approved by Elanco.

  • Leave & Time Off Breadth Time off options are broad, including PTO, flexible leave, and the ability to purchase additional vacation. These provisions are highlighted as supportive of work-life balance.
  • Healthcare Strength Health coverage includes medical, dental, and vision alongside company-paid life, disability, and wellness support. Pet insurance and assistance programs reinforce a comprehensive wellbeing offering.
  • Retirement Support Retirement offerings include a U.S. 401(k) and, for some employees, access to a defined benefit pension. These programs add meaningful long-term value to total rewards.

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The Company
HQ: Greenfield, Indianna
8,445 Employees

What We Do

At Elanco, we work to improve the health of animals through innovative products and services for pets and farm animals around the world. As a global animal health company, we provide solutions that empower our customers to advance a vision of Food and Companionship Enriching Life. Since 1954, Elanco has committed to empowering veterinarians, farmers, and all those who care for animals with the tools they need to help animals live healthy lives. Healthier animals are the key to making our lives better - This is the fundamental belief uniting all global Elanco employees. That’s why we are committed to the idea that our business can be a unique force for good for all in society. Through our Elanco Healthy Purpose™ framework of Environmental, Social and Governance (ESG) commitments, we focus on delivering sustainable solutions to advance the well-being of animals, people and the planet. This program also enables our employees around the world to take paid time off to make an impact as a volunteer, offering their time or talent to give back to our customers, causes and communities. #ElancoHealthyPurpose #WeAreElanco

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