Compliance Specialist Operations

Johnson & Johnson seeks a Senior Compliance Specialist Operations in Schaffhausen to lead production teams, ensure regulatory adherence, and drive operational excellence within the pharmaceutical supply chain.

This position sits within the Manufacturing Pharmaceutical Process Operations function of the Supply Chain. The specialist is tasked with leading a production team responsible for clinical products, including compounding, filling, visual inspection, and device assembly. The core purpose of the role is to implement and guarantee compliance with evolving regulatory standards while managing daily operational performance.

Responsibilities

• Oversee and execute measures to maintain strict adherence to Annex 1 regulations.
• Direct and schedule a production workforce operating on a two-shift basis, focusing on meeting performance targets.
• Coordinate with global and local planning teams to guarantee the timely delivery of both clinical and commercial batches.
• Maintain compliance with EHS, GMP, and regulatory standards, ensuring the team remains ready for audits.
• Manage new product introduction (NPI) and operational projects, supporting qualification and validation efforts.
• Handle adjustments to MES/PAS-X systems, manage MBR/ESP documentation, and maintain necessary records.
• Coach team members to foster continuous improvement through Lean methodologies.
• Provide coverage for other team leads or department management during absences.

Requirements

• Completed vocational training in the pharmaceutical sector or a BSc in Pharmaceutical, Biochemical, or Chemical sciences.
• At least two years of experience working in a Good Manufacturing Practice (GMP) environment.
• Proven experience in production leadership within a two-shift operational model.
• Fluent proficiency in both German and English, including written and spoken communication.

Nice to have

• Experience in project management.

About the company

Johnson & Johnson operates under the guidance of its Credo, emphasizing responsibility to its global workforce. The organization fosters an inclusive environment that values each individual, respecting diversity and dignity while recognizing employee merit.

• Guided by the company Credo with a focus on employee responsibility.
• Commitment to an inclusive work environment where every individual is valued.
• Respect for diversity, dignity, and merit among employees.