Senior Supervisor QA Complaint Approval

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Senior Supervisor, Complaint Quality Approver Team – 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 facility is a strategic launch and growth site for parenteral products with an impressive pipeline of new and innovative products.

• Lead the Complaint Quality Approver team, assigning, prioritizing, and monitoring work to ensure compliant and timely approval of complaint records.
• Provide guidance to approvers on investigation strategy, risk assessment, escalation, evidence requirements, Root Cause Analysis, NC considerations, and alignment of investigation conclusions across products or affiliates when applicable.
• Ensure that approval decisions are made consistently and are supported by objective evidence, applicable procedures, and current regulatory expectations.
• Review complex or high‑risk complaint records, support escalation to Quality leadership, and drive alignment with cross‑functional partners when investigation direction, closure readiness, or quality risk requires leadership input.
• Develop team capability through coaching, feedback, training, and performance management.
• Establish clear expectations for documentation quality, approval rationale, system usage, and stakeholder communication, and ensure the team applies best practices consistently.
• Monitor workload, cycle time, quality metrics, backlog, and recurring investigation trends to identify improvement opportunities, remove barriers, and support sustainable business continuity.
• Contribute to process improvement initiatives, inspection readiness, audit support, and the implementation of global or site quality system changes impacting complaint record approval.

• Complaint Quality Approvers – providing leadership, coaching, work prioritization, and performance feedback.
• Complaint investigation owners and cross‑functional contributors, including Manufacturing, QC, Engineering, Supply Chain, Packaging, MSAT, Regulatory, and Medical Safety.
• Quality leadership for escalation, risk communication, resource planning, operational performance, and decision alignment.
• Other sites and affiliates to align investigation strategy, closure expectations, evidence requirements, and consistent complaint outcomes for site‑manufactured products.
• Audit, inspection readiness, quality systems, and process improvement stakeholders to support compliant execution and continuous improvement.

• Strong knowledge of quality investigations, complaint handling, CAPA and nonconformance concepts in a regulated pharmaceutical or medical product environment.
• Demonstrated ability to lead, coach, and develop a team in a quality organization, including setting priorities and managing performance.
• Strong understanding of cGMP, Good Documentation Practices, data integrity expectations, and applicable U.S. and international regulatory requirements.
• Proven ability to assess complex technical data, investigation conclusions, risk assessments, and escalation needs.
• Ability to make sound quality decisions, communicate clear rationale, and ensure consistency in approval standards.
• Strong stakeholder management skills and ability to operate effectively in a matrixed, cross‑functional, and global environment.
• Ability to drive sustainable process improvements.
• Clear written and verbal communication skills, including the ability to provide actionable feedback and represent the team in leadership discussions.
• Strong organization, prioritization, and decision‑making skills to…