Complaint Quality Approver

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Quality

Quality Assurance

Professional

Schaffhausen, Switzerland

The Complaint Quality Approver 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 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.

The Complaint Record Approver 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 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 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 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 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.

• 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.

• Knowledge of Quality investigations, and corrective and preventive action concepts in a regulated environment is required.
• Proven proficiency in performing or reviewing/approving Quality investigation or Complaint Investigations.
• Understanding of cGMP, Good Documentation Practices, and applicable regulations; familiarity with U.S. and international GMP expectations for pharmaceuticals/medical products.
• 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 quality investigation conclusions 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.