Sr. Supervisor QA Complaint Approval
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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. Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a strategic launch and growth site for parenteral products, and we have an impressive pipeline of new and innovative products.
The Senior Supervisor, Complaint Quality Approver Team is accountable for leading a team of Complaint Quality Approvers responsible for independent, objective review and approval of complaint records. The role provides people leadership, operational oversight, and quality decision support to ensure complaint investigations are complete, scientifically justified, risk-based, and compliant with applicable procedures and regulations. The Senior Supervisor ensures consistent approval practices, timely record progression, appropriate escalation of quality risks, and continuous capability development across the team.
KEY RESPONSIBILITIES
The Senior Supervisor leads the Complaint Quality Approver team and is responsible for assigning, prioritizing, and monitoring work to ensure compliant and timely approval of complaint records. The role provides 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. The Senior Supervisor ensures that approval decisions are made consistently and are supported by objective evidence, applicable procedures, and current regulatory expectations. In addition, the role reviews complex or high-risk complaint records, supports escalation to Quality leadership, and drives alignment with cross-functional partners when investigation direction, closure readiness, or quality risk requires leadership input.
The Senior Supervisor is accountable for developing team capability through coaching, feedback, training, and performance management. The role establishes clear expectations for documentation quality, approval rationale, system usage, and stakeholder communication, and ensures the team applies best practices consistently. The Senior Supervisor monitors workload, cycle time, quality metrics, backlog, and recurring investigation trends to identify improvement opportunities, remove barriers, and support sustainable business continuity. The role also contributes to process improvement initiatives, inspection readiness, audit support, and the implementation of global or site quality system changes impacting complaint record approval.
KEY INTERFACES
- Complaint Quality Approvers to provide 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 as applicable.
- 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.
REQUIRED KNOWLEDGE & SKILLS
- 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 manage multiple priorities, deadlines, and escalations.
EDUCATION & EXPERIENCE REQUIREMENTS
- Master’s degree or PhD in Life Science or related discipline, or equivalent experience, is required.
- Minimum of 3-4 years of experience in quality investigations, complaint handling, quality systems, or a related regulated quality environment is required.
- Prior people leadership, team lead, supervisory, or demonstrated coaching experience is 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