4x Complaint Quality Approver

The company seeks a Complaint Quality Approver in Schaffhausen for a full-time mid-level role. The position focuses on independent review and final quality approval of complaint records to ensure regulatory compliance and thorough investigation.

The company requires a professional to conduct independent and objective reviews of complaint records. This role ensures that all investigations meet scientific standards, follow established procedures, and adhere to regulations. The approver validates that risks are properly assessed, root causes are evidence-based, and necessary stakeholders are engaged before records are finalized.

Responsibilities

• Conducts independent reviews of complaint records at every stage of the investigation lifecycle and grants final quality approval prior to closure.
• Ensures investigation strategies align with standards and verifies that root cause analysis utilizes appropriate methods and tools.
• Collaborates with investigation owners by reviewing progress updates, seeking clarifications, and integrating new information or follow-up narratives into the official record.
• Identifies, manages, and escalates risks, while supporting the implementation of necessary corrective actions.
• Verifies data integrity and ensures conclusions are backed by objective evidence, including consideration of trends and potential recurrence.
• Provides coaching and constructive feedback to issue owners regarding best practices, system usage, and investigation execution.
• Confirms that all required actions, including non-conformances, are defined, assigned, and tracked before approving the complaint record.

Requirements

• Requires knowledge of quality investigations and corrective and preventive action principles within regulated settings.
• Demonstrates proven proficiency in conducting or reviewing quality and complaint investigations.
• Possesses a solid understanding of cGMP, Good Documentation Practices, and relevant regulations, including U.S. and international GMP expectations for pharmaceuticals and medical products.
• Shows strong capability to analyze technical documents, such as batch records and test results, to identify gaps or inconsistencies.
• Can assess whether quality investigation conclusions are supported by objective evidence.
• Evaluates risks and ensures proper escalation and actions in accordance with global and site procedures.
• Exhibits clear written communication skills to provide precise approval rationale and actionable feedback.
• Possesses analytical skills, including the ability to interpret trends and performance metrics.
• Works effectively both independently and within teams, with strong organizational skills to manage deadlines and multiple records.
• Holds a Master’s degree or PhD in Life Science or a related discipline, or equivalent experience.
• Has at least 2-4 years of experience performing or reviewing quality investigations, including complaints, deviations, or nonconformances.
• Experience working within quality systems and understanding applicable regulatory and compliance requirements.
• Demonstrates ability to write clear, concise documentation and provide professional, actionable feedback.
• Shows critical thinking, problem-solving, and decision-making skills.
• Possesses strong organization, prioritization, and time management skills.
• Is business-fluent in English.

About the company

Johnson & Johnson values its global workforce and fosters an inclusive environment where every individual is respected. The company recognizes the diversity and dignity of its employees and acknowledges their merit.

• The company maintains an inclusive work environment where each person is treated as an individual.
• Johnson & Johnson respects the diversity and dignity of its employees.
• The organization recognizes the merit of its employees worldwide.