Job Summary 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 risk assessment, root‑cause analysis, and stakeholder involvement to close complaint records with a clear and consistent outcome.
All Job Posting Locations Schaffhausen, Switzerland
Key Responsibilities
Independent review of complaint records throughout the investigation lifecycle and provide final Quality approval before record closure.
Confirm alignment on investigation strategy, root‑cause analysis and appropriate investigation tools.
Support investigation owners by reviewing updates, requesting clarification or additional evidence, and ensuring accurate integration of new information.
Verify that risks are identified, managed and escalated, and support actions as required.
Ensure data integrity and objective evidence support conclusions.
Address trending and recurrence considerations, and align investigation summary and outcome across sites/affiliates when applicable.
Provide coaching and actionable feedback to issue owners on best practices, system usage and investigation execution.
Define, own and track required actions (including NC, when applicable) before approval.
Key Interfaces
Work in a matrixed environment and collaborate with cross‑functional local and global leaders.
Interface with complaint investigation owner(s) and cross‑functional contributors such as Manufacturing, QC, Engineering, Supply Chain, Packaging, MSAT.
Coordinate with other sites and affiliates to align investigation strategy, evidence and outcome for site‑manufactured product complaints.
Escalate to Quality leadership for risk communication and decision alignment.
Required Knowledge & Skills
Knowledge of Quality investigations and corrective and preventive action concepts in a regulated environment.
Proven proficiency in performing or reviewing/approving Quality investigations 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 (batch records, test results, protocols, procedures) and identify gaps or inconsistencies.
Ability to assess whether investigation conclusions are supported by objective evidence.
Ability to evaluate risk and ensure appropriate escalation and actions.
Clear written communication skills to provide precise approval rationale and actionable feedback.
Analytical skills including trend and performance metric interpretation.
Ability to work independently and in teams; strong organization skills to meet deadlines and manage multiple records.
Education & Experience Requirements
Master’s degree or PhD in Life Science or related discipline (or equivalent experience).
Minimum of 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.
Business‑fluent in English.
Preferred Skills
Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact‑Based Decision Making, Human‑Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP).
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All Job Posting Locations Schaffhausen, Switzerland
Key Responsibilities
Independent review of complaint records throughout the investigation lifecycle and provide final Quality approval before record closure.
Confirm alignment on investigation strategy, root‑cause analysis and appropriate investigation tools.
Support investigation owners by reviewing updates, requesting clarification or additional evidence, and ensuring accurate integration of new information.
Verify that risks are identified, managed and escalated, and support actions as required.
Ensure data integrity and objective evidence support conclusions.
Address trending and recurrence considerations, and align investigation summary and outcome across sites/affiliates when applicable.
Provide coaching and actionable feedback to issue owners on best practices, system usage and investigation execution.
Define, own and track required actions (including NC, when applicable) before approval.
Key Interfaces
Work in a matrixed environment and collaborate with cross‑functional local and global leaders.
Interface with complaint investigation owner(s) and cross‑functional contributors such as Manufacturing, QC, Engineering, Supply Chain, Packaging, MSAT.
Coordinate with other sites and affiliates to align investigation strategy, evidence and outcome for site‑manufactured product complaints.
Escalate to Quality leadership for risk communication and decision alignment.
Required Knowledge & Skills
Knowledge of Quality investigations and corrective and preventive action concepts in a regulated environment.
Proven proficiency in performing or reviewing/approving Quality investigations 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 (batch records, test results, protocols, procedures) and identify gaps or inconsistencies.
Ability to assess whether investigation conclusions are supported by objective evidence.
Ability to evaluate risk and ensure appropriate escalation and actions.
Clear written communication skills to provide precise approval rationale and actionable feedback.
Analytical skills including trend and performance metric interpretation.
Ability to work independently and in teams; strong organization skills to meet deadlines and manage multiple records.
Education & Experience Requirements
Master’s degree or PhD in Life Science or related discipline (or equivalent experience).
Minimum of 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.
Business‑fluent in English.
Preferred Skills
Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact‑Based Decision Making, Human‑Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP).
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