Senior Complaint Quality Approver

Complaint Quality Approver

Location:

Schaffhausen, Switzerland

Job Function:
Quality – Quality Assurance

Job Category:
Professional

Job Description:

At Johnson & Johnson, 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.

• Review complaint records throughout the investigation lifecycle and provide final Quality approval before record closure.
• Confirm alignment on investigation strategy, appropriate Root Cause Analysis, use of investigation tools, and involvement of right stakeholders, including consideration of end‑to‑end supply chain factors.
• Support the investigation owner by reviewing updates, requesting clarification or additional evidence, and ensuring new information and follow‑up narratives are accurately integrated.
• Confirm risks are identified, managed, and escalated, and support actions as required.
• Prior to approval, verify data integrity, ensure conclusions are supported by objective evidence, address trending and recurrence considerations, and ensure investigation summary and outcome are clear and aligned across sites/affiliates.
• Provide coaching and actionable feedback to issue owners on best practices, system usage, and investigation execution.
• Verify required actions (including NC, when applicable) are defined, owned, and appropriately tracked before approving the complaint record.

• Complaint investigation owner(s) and cross‑functional contributors (Manufacturing, QC, Engineering, Supply Chain, Packaging, MSAT).
• Other sites and affiliates 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.
• 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 (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.

• 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.

• 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).