Quality and Compliance Sr. Director

Das ist der Job

pAs Quality Compliance Sr.

Darum lohnt es sich

Director, you will lead the overall Quality function on site, ensuring full compliance with global regulatory standards while driving continuous improvement across the organization.brYour responsibilities will include: /pul liLeading and developing the Quality function (QA, QC, manufacturing quality support, validation, and on-site regulatory activities) /li liEnsuring compliance with applicable standards and regulations, including ISO 13485, ISO 9001, FDA QSR (21 CFR 820), and MDSAP /li liActing as Person Responsible for Regulatory Compliance (PRRC) under EU MDR 2017/745 /li liOverseeing and continuously improving the Quality Management System (QMS) /li liDriving key quality processes such as CAPA, change control, non-conformities, and process validation /li liLeading regulatory inspections and audits (FDA, Notified Bodies, internal and external audits) /li liPartnering cross-functionally with Operations, RD, Clinical, and other stakeholders /li liMonitoring quality performance, identifying trends, and implementing robust corrective actions /li liPromoting a strong culture of quality, compliance, and continuous improvement /li liActing as a key member of the site leadership team, contributing to strategic decision-making /li /ulbrpstrongProfile /strong /pul liProven experience in a senior Quality leadership role within the medical devices industry and with sterile products. /li liStrong knowledge of ISO 13485, FDA QSR (21 CFR 820), and international regulatory frameworks /li liDemonstrated experience leading regulatory inspections (FDA and Notified Bodies) /li liSolid background in manufacturing environments, including process validation and quality control /li liGood understanding of EU MDR and ability to take on PRRC responsibilities /li liStrong leadership and stakeholder management skills /li liAnalytical mindset with a hands-on approach to problem-solving /li /ul pbrstrongLanguages /strong /pul liFluent English is required /li liFrench highly desired and/or German would be an additional asset /li /ulbrul liA competitive compensation package aligned with the seniority of the role /li liRelocation support for candidates moving to Switzerland /li liAn attractive benefits package including additional perks and advantages /li liA strategic position with strong visibility and impact within an international environment /li liWork from home available according to the needs of this role /li /ul