At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Main Purpose

This position is responsible for ensuring the Site Quality System is followed and for ensuring quality products are manufactured and packaged at the site in compliance with applicable regulations such as Japanese GMP / QMS and global LQS / GQS. Some also are assigned to perform batch release to the market by Affiliate Quality.

Responsibilities

The Senior Manager is responsible for the following activities:

General requirements

• Manage team members effectively and develop their capability
• Maintain “Well-Being” for team members according to “Red Book” and Lilly HSE policies,
• Ensure adequate number of qualified resources are available to perform required activities.
• Aid in human resource planning, development and performance management for direct reports
• Identify barriers to productivity within the unit operation and drive continuous improvement
• Mentor, coach and provide feedback to team members and cross-functional partners
• Support cross‑functional decision‑making and operational execution
• Develop and Execute Business & Strategy Planning

Requirements related to Quality Department:

• Make Quality and GMP decisions, including batch release decisions.
• Develop and maintain quality improvement projects.
• Ensure adherence to the quality policy and objectives for the site
• Drive Quality Culture improvement, including Data Integrity.
• Establish and maintain site Quality system for manufacturing operations to meet regulations including Japanese GMP, GQSs and LQSs.
• Establish and maintain site Quality system for marketed products which meet customer expectations.
• Maintain good relationship with Heath Care Authorities/Third parties/Oversea Sites /Lilly global Quality network.
• Collaborate with affiliate QA, other Lilly manufacturing sites, and global SMEs to solve quality issues.
• Participate in and ensure readiness for internal/external audit and inspection

Business Title Sr. Manager, Quality Assurance

The minimum requirements for the performance of the job: Education, Certificate, Knowledge, Experience/Background, Qualification.

Educational background:

• Pharmaceutical Science, Chemistry, Biochemistry (bachelor degree or above)

Work experience:

• Quality background with GMP and/or TS&MS knowledge and experience.

Personal Consideration

Knowledge and Skills desirable to perform Role:

• Understanding the science of manufacturing.
• Understanding local and global applicable regulations.
• Modeling strong leadership behaviors.
• Having a global perspective.
• Capability to solve quality issues.
• Ability to influence diverse groups.
• Demonstrated decision-making and problem-solving skills
• Ability to work as part of a team
• Demonstrated negotiating coaching and mentoring skills
• Experience leading teams

Language Requirements

Japanese and English:

Eli Lilly Japan社員の方へ、

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あらかじめ応募にあたっては、詳細は以下リンク先にある情報をご確認とご理解を頂くようお願いいたします。

https://now.lilly.com/landingoverview/JP-change-in-career-system/JP-changes-in-my-career-faqs

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.

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