[Innovative Medicine] Specialist, Quality System 2 Group, Quality Operations Dept., Manufacturing and Supply Div. (Fuji Plant)

Johnson & Johnson is hiring a [Innovative Medicine] Specialist, Quality System 2 Group, Quality Operations Dept., Manufacturing and Supply Div. (Fuji Plant). Level rates it ; you can apply on Johnson & Johnson.

Level's read on this job

On Level's scale, this role is Little AI ●○○○: aI is not part of the work.
The posting mentions Gmp, Gctp and quality assurance among its tools and skills.
Level classes it as a mid-level role.
Johnson & Johnson has 1,700+ other open roles on Level.

AI in this role

Manage quality systems, data integrity, and compliance activities under GMP/GCTP regulations at a manufacturing plant.

GmpGctp

quality-assurancedata-integritydeviation-managementchange-controlcompliance

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Shizuoka, Japan

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

職務概要 Position Summary:

本職務記述書は、品質システムGに適用する。This Job Description applies to the position of Quality System Group at JPKK, Fuji Plant.

医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律、GMP/GCTP及びコーポレートポリシー、手順に従い、与えられた品質システム、コンプライアンスの関わる業務を実施する。
In accordance with the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc., GMP/GCTP regulations, and corporate policies and procedures, perform assigned quality system– and compliance-related activities.

主な職務及び主な責任 Major Job Duties and Responsibilities:

データインテグリティの遵守・推進、逸脱管理、変更管理などのGMP/GCTP活動
製造販売業者との窓口として品質取決めの維持、逸脱などの報告要件の実施、査察の対応
他グループメンバーが担当するGMP/GCTP活動、業態管理などのサポート
トラブルシューティング、逸脱調査の準備
業務改善
新しい取り組みのリードもしくはサポート
Manage GMP/GCTP activities such as Data Integrity, Deviation management control, Change control.
Acting as the point of contact with the Marketing Authorization Holder, including maintaining Quality Agreements, implementing reporting requirements for deviations and related events and audit management.
Support other group members’ GMP/GCTP activities and license management activities.
Trouble shooting and investigation of deviation.
Improvement initiatives
Lead or support new initiatives.

職務の要件 Job Requirement

教育/経験Education and Experiences:

薬学、理化学または生物学の学位を修了していることが望ましい。 Degree in Pharmacy, physics and chemistry or biology is preferable.
製薬業界における品質管理、品質保証、規制遵守などの分野での5年以上の経験が望ましい。More than 5 years of experience in various areas such as Quality control, Quality Assurance, Regulatory Compliance in pharmaceutical industry is desirable.

知識、資格、及び技能 Knowledge, Qualification and Skills:

GMP/GQP/QMS品質システムに精通している。Knowledgeable of GMP/GQP/QMS quality systems.
ビジネスレベルの英語力を有していることが望ましい。Business-level English proficiency
ソフトウエアアプリケーションを効果的に使用できる能力を有していること。例: MSオフィス、Trackwise
Have an ability to effectively use software applications. Ex. MS office, Trackwise

行動特性Core Competencies:

リーダーシップ Leadership skills
コーチング Good coaching
問題解決能力 problem-solving skills
チームワーク、コミュニケーションス及びコラボレーション能力 Excellent communication, Collaboration and teamwork
プロジェクトマネージメント力 Project Management skills
顧客フォーカス Customer focus

#LI-Onsite

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社内公募ガイドライン

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在籍期間に関わらず、書類選考を通して１次面接に進んだ場合は、社内公募に応募し選考に進むことを上司に報告してください。
社内紹介を行う場合は、Career Hub上の“社内紹介制度の概要”の詳細を理解した上で、コンプライアンスを守って紹介したものとみなします。

Required Skills:

Preferred Skills:

Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards

How we rate this

[Innovative Medicine] Specialist, Quality System 2 Group, Quality Operations Dept., Manufacturing and Supply Div. (Fuji Plant) at Johnson & Johnson rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

●●●● Builds AI80 to 100
●●●○ Works on AI60 to 79
●●○○ Uses AI40 to 59
●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.

Key facts

[Innovative Medicine] Specialist, Quality System 2 Group, Quality Operations Dept., Manufacturing and Supply Div. (Fuji Plant) is an open job at Johnson & Johnson.
Level rates this role AI Level 1 of 4: Little AI.
The role is based in Shizuoka, Japan.
The job was posted on August 3, 2026.
Seniority: mid.
Applications are handled by Johnson & Johnson. Apply on Johnson & Johnson

Prepare for this job

Built from this posting and from similar jobs on Level.

Skills and AI tools this role asks for

Quality AssuranceData IntegrityDeviation ManagementChange ControlComplianceGmpGctp

Questions you could be asked

Tell me about a project where quality assurance was part of your work. What did you do?
Tell me about a project where data integrity was part of your work. What did you do?
Tell me about a project where deviation management was part of your work. What did you do?
Tell me about a project where change control was part of your work. What did you do?
Tell me about a project where compliance was part of your work. What did you do?

Adapt your resume

List these exact terms on your resume: Quality Assurance, Data Integrity, Deviation Management, Change Control, and Compliance. An applicant tracking system matches the wording, not the idea.
Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.

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