Specialist Quality Systems

Johnson & Johnson seeks a Specialist Quality Systems in Schaffhausen to manage key QMS processes, ensure regulatory compliance, and support continuous improvement within a GMP-regulated environment.

This position serves as a dedicated resource for the Quality Systems team and the local Business Process Owner at the Schaffhausen site. The primary objective is to ensure the compliant, efficient, and sustainable operation of critical Quality Management System processes. The specialist will cultivate deep expertise in one specific process area while simultaneously providing essential support and governance across other QMS functions.

Responsibilities

• Build and maintain deep expertise in one designated Quality Systems process while offering guidance, system support, and continuous improvement input for Change Control, NC/CAPA, Commitments, Escalations, and related metrics.
• Deliver daily assistance, troubleshooting, coaching, and training to end-users regarding relevant Quality Systems procedures.
• Coordinate and facilitate review boards and alignment meetings, focusing on process performance monitoring, KPI reviews, and resolving overdue or at-risk records.
• Assist the local Business Process Owner in executing global and local initiatives, including process enhancements and system upgrades.
• Remain actively engaged in multiple Quality Systems areas, with specific duties assigned according to business needs and process priorities.
• Act as the subject matter expert for audit and inspection readiness within the assigned process area and provide support for other QMS topics as required.
• Ensure strict adherence to company procedures, Good Manufacturing Practices (GMP), and all applicable regulatory standards.

Requirements

• A Bachelor’s degree in a scientific, technical, pharmaceutical, engineering, or related discipline, or equivalent professional experience.
• Prior experience working in a GMP-regulated sector such as pharmaceuticals, biotechnology, or medical devices.
• Solid knowledge of Quality Systems processes, with proven experience in areas like Change Control, Non-Conformance, CAPA, Risk Assessments, Commitment Records, Escalations, and quality metrics.
• Hands-on experience with computerized quality management systems and the ability to support end-users with system or process inquiries.
• Excellent verbal and written communication abilities, with a track record of effective collaboration with cross-functional stakeholders.
• Capacity to work autonomously with minimal supervision, manage competing priorities, meet deadlines, and maintain a solution-oriented attitude.
• Fluency in English.

Nice to have

• Proficiency in German.

About the company

Johnson & Johnson operates with a strong sense of responsibility toward its global workforce. The company fosters an inclusive environment that treats every individual with respect, honoring their diversity, dignity, and merit.

• Commitment to employee responsibility and well-being across global operations.
• Inclusive workplace culture that values each person as an individual.
• Recognition of employee diversity, dignity, and professional merit.

How to apply

Documents to submit:

• CV