Senior Supervisor QA Complaint Approval

Darum lohnt es sich

ph3Senior Supervisor, Complaint Quality Approver Team /h3 pLocation: Schaffhausen, Switzerland /p pCilag 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. /p h3Key Responsibilities /h3 ul liLead and provide people leadership to the Complaint Quality Approvers team. /li liAssign, prioritize, and monitor work to ensure compliant and timely approval of complaint records. /li liGuide approvers on investigation strategy, risk assessment, escalation, evidence requirements, RCA, NC considerations, and alignment across products or affiliates. /li liEnsure consistent approval decisions are supported by objective evidence, procedures, and regulatory expectations. /li liReview complex or high‑risk complaint records, support escalation to Quality leadership, and drive alignment with cross‑functional partners. /li liDevelop team capability through coaching, feedback, training, and performance management. /li liMonitor workload, cycle time, quality metrics, backlog, and recurring trends to identify improvement opportunities. /li liContribute to process improvement initiatives, inspection readiness, audit support, and implementation of global or site quality system changes. /li /ul h3Key Interfaces /h3 ul liComplaint Quality Approvers – leadership, coaching, work prioritization, and performance feedback. /li liComplaint investigation owners and cross‑functional contributors: Manufacturing, QC, Engineering, Supply Chain, Packaging, MSAT, Regulatory, and Medical Safety. /li liQuality leadership for escalation, risk communication, resource planning, operational performance, and decision alignment. /li liOther sites and affiliates to align investigation strategy and expectations for site‑manufactured products. /li liAudit, inspection readiness, quality systems, and process improvement stakeholders to support compliant execution and continuous improvement. /li /ul h3Required Knowledge Skills /h3 ul liStrong knowledge of quality investigations, complaint handling, CAPA, and nonconformance concepts in a regulated pharmaceutical or medical product environment. /li liDemonstrated ability to lead, coach, and develop a team in a quality organization. /li liStrong understanding of cGMP, Good Documentation Practices, data integrity expectations, and applicable U.S. and international regulatory requirements. /li liProven ability to assess complex technical data, investigation conclusions, risk assessments, and escalation needs. /li liAbility to make sound quality decisions, communicate clear rationale, and ensure consistency in approval standards. /li liStrong stakeholder management skills and ability to operate effectively in a matrixed, cross‑functional, and global environment. /li liAbility to drive sustainable process improvements. /li liClear written and verbal communication skills, including the ability to provide actionable feedback and represent the team in leadership discussions. /li liStrong organization, prioritization, and decision‑making skills to manage multiple priorities, deadlines, and escalations. /li /ul h3Education Experience Requirements /h3 ul liMaster’s degree or PhD in Life Science or related discipline, or equivalent experience – required. /li liMinimum of 3–4 years of experience in quality investigations, complaint handling, quality systems, or a related regulated quality environment – required. /li liPrior people leadership, team lead, supervisory, or demonstrated coaching experience – strongly preferred. /li liExperience performing, reviewing, approving, or providing oversight for complex quality investigations, complaints, deviations, nonconformances, or similar quality events. /li liExperience working with cross‑functional stakeholders and quality leadership to manage risk, escalation, and decision alignment. /li liDemonstrated ability to drive process improvement, inspection readiness, and consistent execution of quality system requirements. /li liProven critical thinking, problem‑solving, communication, and people leadership skills. /li liBusiness‑fluent in English. /li /ul h3Required Skills /h3 ul liBusiness Savvy /li liCompliance Management /li liCorrective and Preventive Action (CAPA) /li liCross‑Functional Collaboration /li liDeveloping Others /li liFact‑Based Decision Making /li liGive Feedback /li liHuman‑Centered Design /li liInclusive Leadership /li liISO 9001 /li liLeadership /li liQuality Control (QC) /li liQuality Management Systems (QMS) /li liQuality Standards /li liRisk Assessments /li liStandard Operating Procedure (SOP) /li liTeam Management /li /ul h3Preferred Skills /h3 ul liContinuous Improvement /li liStrategic Thinking /li liData Analysis /li /ul /p #J-18808-Ljbffr