[Innovative Medicine] Complaint Quality Approver, Operational Quality Group (Fuji Plant)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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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.

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The Complaint Handling Specialist is accountable for independent objective review and approval of complaint records to ensure investigations are complete scientifically justified and compliant with applicable procedures and regulations. The Complaint Handling Specialist also supports proper complaint handling through leading investigations. The role confirms that risk is assessed root cause and actions are adequately supported by evidence required stakeholders are involved and the complaint record can be closed with a clear and consistent outcome.

Major Job Duties and Responsibilities:

• The Complaint Handling Specialist independently reviews complaint records throughout the investigation lifecycle and provides the final Quality approval before record closure. The approver confirms alignment on investigation strategy Root Cause Analysis (RCA) is appropriate that appropriate investigation tools are used and that the right stakeholders are involved including consideration of end-to-end supply chain factors as applicable. During execution the approver supports the investigation owner by reviewing updates requesting clarification or additional evidence and ensuring new information and follow-up narratives are accurately integrated into the complaint (PQMS) record including any actions required based on new information. The approver confirms risks are identified managed and escalated and supports actions as required. Prior to approval the approver verifies data integrity and that conclusions (including RCA) are supported by objective evidence confirms trending and recurrence considerations are addressed and ensures the investigation summary and outcome are clear and aligned across sites/affiliates when applicable. Additionally the approver will provide coaching and actionable feedback to issue owners on CAPA best practices system usage and investigation execution. Finally the approver verifies required actions (including NC when applicable) are defined owned and appropriately tracked before approving the complaint record.
• When acting as the investigator the Complaint Handling Specialist is responsible for conducting the investigation in accordance with the investigation requirements described above for the approver role while closely collaborating with the market authorization holder sourcing site and business partners to compile the investigation report document it in the complaint (PQMS) record and drive the record through closure.
• The Complaint Handling Specialist is responsible for executing managing trending and improving the site-based complaints process to ensure compliance with applicable requirements.

KEY INTERFACES

• Must be able to effectively operate in a matrixed environment and interact with cross functional local and global leaders on a regular basis.
• Complaint investigation owner(s) and cross-functional contributors (e.g. Manufacturing QC Engineering Supply Chain Packaging MSAT).
• Other sites and affiliates (as applicable) to align investigation strategy evidence and outcome for site-manufactured product complaints.
• Quality leadership for escalation risk communication and decision alignment.
• External manufacturers/partners and laboratories (as applicable) to obtain and evaluate investigation input and analytical results.

Education and Experiences:

• Bachelors degree in Life Science or related discipline (or equivalent experience) is required.
• Minimum of 2-4 years of experience performing and/or reviewing quality investigations (complaints deviations nonconformances or similar quality events).
• Experience working within quality systems and with applicable regulatory and compliance requirements.
• Demonstrated ability to write clear concise documentation and provide professional actionable feedback.
• Proven critical thinking problem-solving and decision-making skills.
• Strong organization prioritization and time management skills

Knowledge Qualification and Skills:

• Knowledge of complaint handling investigations and corrective and preventive action concepts in a regulated environment.
• Understanding of cGMP Good Documentation Practices and applicable regulations; familiarity with U.S. and international GMP expectations for pharmaceuticals/medical products (as applicable to the site).
• Strong ability to review technical data and documents (e.g. batch records test results protocols procedures) and identify gaps or inconsistencies.
• Ability to assess whether conclusions (including root cause) are supported by objective evidence.
• Ability to evaluate risk and ensure appropriate escalation and actions according to global and site procedures.
• Clear written communication skills to provide precise approval rationale and actionable feedback.
• Analytical skills including ability to interpret trends and performance metrics.
• Ability to work independently and in teams; strong organization skills to meet deadlines and manage multiple records.
• Business Conversation Level English/Japanese

Core Competencies:

• Collaboration teamwork
• Solid Credo Values
• Customer Focus
• Emphasis on EHS Rules/Procedures Compliance
• Undelayed reporting of incidents near misses etc.

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