Complaint Quality Review Lead

Johnson & Johnson Innovative Medicine; Schaffhausen; Sur place; CHF 110 000 - 160 000; Plein temps

Résumé du poste

Johnson & Johnson in Schaffhausen is seeking a Complaint Quality Approver to independently review complaint records, ensure investigations are complete, scientifically justified, and compliant with applicable procedures and regulations.

The role requires assessing risk, confirming root cause analyses, involving the right stakeholders, and ensuring outcomes are clearly documented and supported by evidence across sites.

Qualifications

• Knowledge of Quality investigations and CAPA concepts in a regulated environment.
• Proven proficiency in performing or reviewing quality investigations.
• Understanding of cGMP, Good Documentation Practices, and applicable regulations; familiarity with GMP expectations for pharma/medical products.
• Ability to review technical data and identify gaps or inconsistencies.
• Ability to evaluate whether conclusions are supported by objective evidence.
• Ability to assess risk and ensure escalation and actions per procedures.

Responsabilités

• Review complaint records across the investigation lifecycle and provide final Quality approval before record closure.
• Confirm alignment on investigation strategy and appropriate use of analysis tools.
• Engage stakeholders across sites and functions, including end-to-end supply chain considerations.
• Provide coaching and actionable feedback to issue owners on best practices and system use.
• Verify actions are defined, tracked, and that conclusions are supported by evidence before approval.

Connaissances

Quality investigations

GMP compliance

Data review

Judgment/evidence

Risk assessment

Written communication

Analytics

Teamwork & organization

Quality investigations

Formation

Master's/PhD Life Science

Experience in quality investigations

Quality systems/regulatory

Technical writing

Critical thinking

Time management

Description du poste

Johnson & Johnson in Schaffhausen is seeking a Complaint Quality Approver to independently review complaint records, ensure investigations are complete, scientifically justified, and compliant with applicable procedures and regulations.

The role requires assessing risk, confirming root cause analyses, involving the right stakeholders, and ensuring outcomes are clearly documented and supported by evidence across sites.