Complaint Quality Approver

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

Job Posting Locations:
Schaffhausen, Switzerland

Cilag AG in Schaffhausen belongs to the group of Johnson & Johnson Innovative Medicine and manufactures high quality pharmaceutical products, active pharmaceutical ingredients (APIs) and medical devices. The Schaffhausen facility is a strategic launch and growth site for parenteral products and has an impressive pipeline of new and innovative products.

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.

• Independently reviews complaint records throughout the investigation lifecycle and provides final quality approval before record closure.
• Confirms alignment on investigation strategy, ensures Root Cause Analysis is appropriate and that appropriate investigation tools are used, and that the right stakeholders are involved, including consideration of end-to-end supply chain factors as applicable.
• 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.
• Verifies that risks are identified, managed and escalated, supports actions as required, and confirms 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.
• Provides coaching and actionable feedback to issue owners on best practices, system usage, and investigation execution.
• Verifies 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 (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 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 (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.

Master’s degree or Ph.D. in Life Science or related discipline (or equivalent experience) is required. Minimum of 2‑4 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 Behavior
• Coaching
• Compliance Management
• Continuous Improvement
• Data Analysis
• Detail‑Oriented
• Goal Attainment
• Human‑Centered Design
• Internal Controls
• Issue Escalation
• Problem Solving
• Process Oriented
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards