[Innovative Medicine] Operational Quality Supervisor (Night Shift), Operational Quality Group, Quality Operations Dept., Manufacturing and Supply Div. (Fuji Plant)

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 https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Supplier Quality

Job Category:

People Leader

All Job Posting Locations:

Sunto, 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、品質オペレーション G スーパーバイザーに適用する。 This Job Description applies to the position of Operational Quality Group Supervisor at JPKK, Fuji Plant.
• 品質オペレーション G スーパーバイザーは、製造に関わる業務について品質における全体的な 方向性を示す。 This individual provides quality perspective direction for all production activities at JPKK, Fuji Plant.

法規制の順守に関する責任 / Regulatory Compliance Responsibilities:

• 品質オペレーション G スーパーバイザーは、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、麻薬及び向精神薬取締法及びコーポレートポリシー手順に従う。
• Operational Quality Group Supervisor will comply with Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, GMP/GCTP, Narcotics and Psychotropics Control Law all corporate and site policies and procedure.

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

Quality Operations Support Activities:

To effectively support both direct and indirect operations from a quality perspective within the Quality Operations area, the individual must perform the following activities based on assigned training:

Night Shift Responsibilities:

• Operational Support:
  • Assist the Operational Quality Group staff in their daily activities during the night shift, ensuring continuous quality oversight.
• Routine Rounds:
  • Collaborate with night shift staff to conduct routine rounds, ensuring Good Manufacturing Practices (GMP), compliance, and safety standards are consistently met in all GMP areas.
• Incident Reporting:
  • Ensure that any quality and compliance-related events occurring on the shop floor during the night shift are promptly reported to the quality team. Events must be managed swiftly and appropriately by the department responsible, with supervisors providing direct or indirect support during investigations, focusing on identifying root causes.
• Corrective and Preventive Actions:
  • Work in collaboration with managers and supervisors to pinpoint effective corrective and preventive actions that mitigate potential recurrences of issues, thus achieving production goals and minimizing quality and compliance problems. Occasionally lead root cause analysis activities using appropriate methodologies.
• Implementation Oversight:
  • Ensure the timely execution of assigned corrective and preventive actions to address any identified issues.
• Promoting Quality Culture:
  • Support the operations group in fostering a quality culture as an integral part of the systematic approach to all processes.
• Cross-Department Support:
  • Assist various departments by providing necessary solutions to navigate critical situations during night operations.
• Inspection Preparation:
  • Aid in the preparation for external and internal inspections, actively participate in internal audits, and contribute to business processes such as Johnson & Johnson Production System (JJPS) and Kaizen by advocating for the implementation of improvement actions.
• Process Monitoring:
  • Ensure the adequacy of processes and the performance of individual subsystems through regular checks and continuous monitoring.
• Procedure Management:
  • Oversee the issuance and updating of operational procedures (Work Instructions & Standard Operating Procedures), promoting continuous improvement in GMP processes, and supporting projects for new machine and production line installations with timely reviews.
• Training Coordination:
  • Ensure that personnel involved in procedural changes receive adequate training, prepare necessary materials, and conduct the group's annual GMP re-training for operations.
• Technological Innovation:
  • Contribute to maintaining a high level of technological innovation and process improvement by guiding projects and initiatives that follow Lean and JJPS methodologies.
• Performance Indicators:
  • Ensure that performance indicators for the areas of responsibility align with expected results, analyzing and trending defect data appropriately.
• NPI Coordination:
  • Assign team members as Quality Assurance (QA) points of contact for New Product Introduction (NPI) launch activities.

Quality & Compliance:

• Adhere to GMP and compliance regulations while performing all work activities.
• Create, modify, and ensure the updating of necessary procedures and work instructions.
• Complete all assigned technical training and required updates in a timely manner.
• Assist in training and reinforcing compliance measures (such as Data Integrity) within the production area.

Environmental Health and Safety (EHS):

• Work in compliance with established safety procedures and regulations.
• Promptly report any situations that could jeopardize the health and safety of employees or the environment to supervisors.
• Participate in information sessions, training, and health surveillance provided for the job.
• Recognize the significance of Johnson & Johnson's assets and take measures to protect them from theft, loss, or destruction.

Computer & Automation Systems:

• Utilize necessary IT tools effectively to carry out work activities.
• Adhere to Johnson & Johnson's Worldwide Information Asset Protection Policy, recognizing the importance of safeguarding information from unauthorized access, disclosure, and other risks.

職務の要件 / Job Requirement:

教育/経験 / Education and Experiences:

• 薬学、科学または工学の学位を修了していることが望ましい
• Degree in Pharmacy, Science or Engineering is preferable.

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

• GMP/GCTP and Data integrity
• 品質システムに精通している Knowledgeable of quality system.
• Pharmaceutical regulations, standards, and guidelines
• Communication skill to articulate Japan needs to stakeholders

行動特性Core Competencies:

• コラボレーション、チームワーク Collaboration and teamwork. 
• 確固たるクレドーバリュー Credo value of integrity.
• 顧客重視 Customer focus.
• EHS、手順に従う Comply with EHS rules and procedures at all times.
• インシデント、ニアミス等の報告 Report all incidents, accidents, and near miss events.

This is a night shift position, and the working hours will be 18:45 to 3:45 (Break: 23:00-24:00) with total 8 hours / day. The company may require employees to work outside of regular working hours or on holidays due to business needs.

#LI-Onsite 

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