<品質保証部>Site Compliance and Quality Systems (Associate) Director/部長/西神工場(神戸市内)

Eli Lilly and Company; Indiana (PA); On-site; USD 120,000 - 160,000; Full time

Job summary

A leading pharmaceutical company seeks an Associate Director of Site Compliance and Quality Systems. This role offers the opportunity to lead quality teams, ensure GMP compliance at the Seishin Manufacturing Site, and manage interactions with regulatory authorities. Candidates should possess a pharmaceutical degree, relevant GMP experience, and strong leadership skills. Join us in transforming lives through dedication to quality and compliance in healthcare.

Benefits

Housing Allowance

Transportation Compensation

Flexible Work Hours

Complete Weekends Off

Annual Leave

Qualifications

• 5 years GMP work experience in a pharmaceutical manufacturing facility required.
• Proficiency in Japanese regulations on pharmaceutical products preferred.
• Eligibility as Pharmaceutical Manufacturing Manager necessary.

Responsibilities

• Manage the site quality system and ensure GMP compliance.
• Lead the Quality Systems and GMP Compliance team.
• Develop and implement audit and inspection readiness programs.

Skills

Leadership

Critical Thinking

Quality Assurance

Regulatory Compliance

Networking

Education

Pharmaceutical degree

Job description

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.

Job Title

Site Compliance and Quality Systems (Associate) Director
Department

Seishin Quality
Position Title

Associate Director / Director
Supervisor Title

Site Quality Leader (Sr. Director or above)
Main Purpose

This position is responsible for the site quality system and for GMP compliance of the Seishin Manufacturing Site. It ensures that the products manufactured and packaged at the site follow and comply with applicable regulations and GMP requirements, such as Japanese GMP / QMS and global LQS / GQS.

The person in this position is also the designed Pharmaceutical Manufacturing Manager(製造管理者) and Manufacturing Manager of Biological-origin

Products(生物由来製品製造管理者) and is the point of contact with the Japanese local authorities.

Responsibilities

The Seishin Site Compliance and Quality Systems Leader is responsible for the following activities:

General requirements

• Provide technical and administrative leadership to the Quality Systems and GMP Compliance team: Manage team members effectively and develop their capabilities
• Maintain “Well-Being” for team members according to “Red Book” and Lilly HSE policies,
• Ensure that team members are qualified and required trainings are carried out in a timely manner
• Contribute to the Business & Strategy Planning by providing inputs related to Compliance and Quality Systems
• Lead the Site Quality Lead Team

Requirements related to the Quality Department

• Develop, ensure implementation and monitor the Site Quality Plan and the Site Self-inspection plan
• Develop, ensure implementation and maintain the Site Quality Policy, Site Quality Manual and Site Master File
• Develop and implement audit and inspection readiness program for the Site.
• Host GMP inspections and audits for Pharmaceutical products, Medical Devices and drug/device combination products
• Establish, implement and maintain site quality system for marketed products, which meet customer expectations, local regulations and global quality standards.
• Establish, implement and maintain GQP/QMSGMP Standards and SOPs according to the requirement of current Pharmaceuticals and Medical Devices Law
• Drive Site Quality Culture initiatives, integrating focus areas such as Data Integrity.
• Make Quality and GMP decisions in a timely manner.
• Participate in global quality and Compliance projects
• Deliver quality improvement projects.
• Maintain good relationship with Heath Care Authorities/ Supplying Sites /CMOs manufacturing on behalf of Lilly Japan and Lilly global quality network.
• Collaborate with affiliate QA to solve quality issues
• Ensure Site education and provide consultation on local regulations and corporate standards.

• Provide performance metrics, quality metrics and trend evaluations on Quality Systems, including ad-hoc, periodic review and trend evaluation of Complaints, Deviations, Change Controls, etc.
• Ensure adequate documentation control and retention in alignment with local and Lilly global requirements.
• Develop the process and ensure adequate implementation and maintenance of Management review of Quality Systems, Site Compliance Reports, gap assessment of global quality standards and local regulatory guidance documents
• Ensure adequate quality oversight is provided Material Suppliers and Service Providers.
• Develop and ensure execution and monitoring of Supplier and Service Provider quality systems, audit plan and periodic review of Supplier/Service Providers performance.
• Ensure there is an appropriate Risk Management program, risk register and QRM related elements
• Ensure there is an appropriate CAPA program

Educational background:

• Pharmaceutical degree or other degrees that ensure eligibility as Product Security Pharmacist and Biological Product Security Pharmacist
• Work experience required to be eligible as Pharmaceutical Manufacturing Manager(製造管理者) and Manufacturing Manager of Biological-origin Products(生物由来製品製造管理者)

Work experience:

• 5 years GMP work experience in a pharmaceutical manufacturing facility
• Experience in Quality assurance, Quality Control and/or TS&MS
• Knowledge of Japanese regulations on pharmaceutical products, biological products and medical devices

Knowledge, Skills and necessary traits to perform Role:

• Understand the scientific and technical principles associated with the manufacturing processes.

• Understand local and global applicable regulations.
• Have a global and external perspective. Strong networking and benchmarking skills.
• Critical thinking and capability to solve quality issues. Technical writing skills.
• Model leadership behaviors and demonstrate strong leadership: Ownership and accountability to define and deliver the Site quality agenda, to lead by influence and to coach and develop others.
• Experience managing audits and inspections

Others:

• Language Requirements Japanese (native level) and English (Business level)
• From the perspective of employee well-being and productivity, Lilly has established a commuting distance and time limit policy. Specifically, the maximum allowable commuting distance is within 90 km and commuting time should not exceed 90 min from candidates nearest station to the workplace using the cheapest public transportation route. If candidates live further away than the above range, they will generally be required to relocate to a location within commuting distance (rented company housing may be provided). The above applies even if commuting by car is permitted.

【就業場所】西神工場（神戸市内）

従事すべき業務の変更の範囲 ：当社業務全般

就業場所の変更の範囲 ：将来のキャリアの一環として、神戸本社・東京支社・西神工場・ 海外オフィスでの勤務をする場合もありうる

<処遇>

【給与】当社規定により優遇します

【諸手当】住宅手当、通勤交通費など

【昇給】有り

【賞与】年一回個人業績結果及び会社業績結果に基づく業績変動賞与を翌年3月に支給する。

【勤務時間】8：45～17：30

【時間外手当】対象外

【清算制フレックス勤務】適応あり。フレキシブルタイム：5時～22時内で勤務。（ただし、一斉休憩を除く）1日の必要最低労働時間：4時間（半日休暇時は2時間）一斉休憩：12時～13時

【在宅勤務制度】あり

【受動喫煙対策】あり就業場所全面禁煙

【休日休暇】完全週休2日制（土・日曜日）、祝日、年末年始・夏期 ※工場カレンダーによる *年間休日125日、年次有給休暇、慶弔等

【保険】雇用・労災・健康・厚生年金保険

【定年制】有（60歳）

【継続雇用制度】：有（65歳まで）

【有給休暇】

入社月１－６月７月８月９月１０月１１月１２月

10 54 32 1 0

【試用期間】 6か月間試用期間中での賃金の違いはございません

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