Senior Supervisor QA Complaint Approval

Senior Supervisor, Complaint Quality Approver Team

Location:

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 we have an impressive pipeline of new and innovative products.

• Lead and provide people leadership to the Complaint Quality Approvers team.
• Assign, prioritize, and monitor work to ensure compliant and timely approval of complaint records.
• Guide approvers on investigation strategy, risk assessment, escalation, evidence requirements, RCA, NC considerations, and alignment across products or affiliates.
• Ensure consistent approval decisions are supported by objective evidence, procedures, and regulatory expectations.
• Review complex or high‑risk complaint records, support escalation to Quality leadership, and drive alignment with cross‑functional partners.
• Develop team capability through coaching, feedback, training, and performance management.
• Monitor workload, cycle time, quality metrics, backlog, and recurring trends to identify improvement opportunities.
• Contribute to process improvement initiatives, inspection readiness, audit support, and implementation of global or site quality system changes.

• Complaint Quality Approvers – leadership, coaching, work prioritization, and performance feedback.
• Complaint investigation owners and cross‑functional contributors:
  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 and expectations 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.
• 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 manage multiple priorities, deadlines, and escalations.

• Master’s degree or PhD in Life Science or related discipline, or equivalent experience – required.
• Minimum of 3–4 years of experience in quality investigations, complaint handling, quality systems, or a related regulated quality environment – required.
• Prior people leadership, team lead, supervisory, or demonstrated coaching experience – strongly preferred.
• Experience performing, reviewing, approving, or providing oversight for complex quality investigations, complaints, deviations, nonconformances, or similar quality events.
• Experience working with cross‑functional stakeholders and quality leadership to manage risk, escalation, and decision alignment.
• Demonstrated ability to drive process improvement, inspection readiness, and consistent execution of quality system requirements.
• Proven critical thinking, problem‑solving, communication, and people leadership skills.
• Business‑fluent in English.

• Business Savvy
• Compliance Management
• Corrective and Preventive Action (CAPA)
• Cross‑Functional Collaboration
• Developing Others
• Fact‑Based Decision Making
• Give Feedback
• Human‑Centered Design
• Inclusive Leadership
• ISO 9001
• Leadership
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Risk Assessments
• Standard Operating Procedure (SOP)
• Team Management

• Continuous Improvement
• Strategic Thinking
• Data Analysis