# Director, Regulatory Compliance – BioT at Johnson & Johnson

Johnson & Johnson is hiring a Director, Regulatory Compliance – BioT. Level rates it Little AI ●○○○; you can [apply on Johnson & Johnson](https://jobsbylevel.com/go/f23bf137-e5b2-4e3c-86b5-ed12b3b050c9?utm_medium=ai-agent).

AI Level 1, AI centrality 10 out of 100. Schaffhausen, Switzerland.

## Details

- Company: [Johnson & Johnson](https://jobsbylevel.com/companies/johnson-johnson)
- AI level: AI Level 1 (score 10 out of 100)
- Location: Schaffhausen, Switzerland
- Posted: October 22, 2026
- Apply: https://jobsbylevel.com/go/f23bf137-e5b2-4e3c-86b5-ed12b3b050c9?utm_medium=ai-agent
- Free CV review for this job: https://jobsbylevel.com/cv-review?job=director-regulatory-compliance-biot-at-johnson-johnson-4a5cf1

## Prepare for this job

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## Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality & Compliance Audit Job Category: Professional All Job Posting Locations: Schaffhausen, Switzerland Job Description: J&J is recruiting for a Director, Regulatory Compliance – BioT reporting to the Sr Dr Regulatory Comp, Large Molecule. Position Summary The Director, Regulatory Compliance is the senior Site-Based Compliance leader responsible for providing independent compliance leadership, maintaining visibility of the site compliance-risk posture, promoting continuous inspection readiness, enabling timely escalation, and strengthening organizational learning at a Biotherapeutics manufacturing site. The role serves as a strategic compliance partner to Site Leadership, Quality, Manufacturing, MSAT, Engineering, Supply Chain, Regulatory Affairs, and Quality Control. The Director brings an independent regulatory compliance perspective to significant risks and decisions and helps connect site signals to platform and enterprise priorities. The role requires deep knowledge of biologics manufacturing operations and the regulatory and operational risks associated with aseptic processing, cell culture operations, downstream purification, viral safety, contamination-control strategies, environmental monitoring, process validation, technology transfer activities, and product lifecycle management. As a people leader, the Director builds and develops a high-performing compliance organization and strengthens compliance capability across the site. Mission of the Role Enable the site to maintain a sustained state of compliance and inspection readiness by providing proactive and independent compliance leadership, strengthening risk visibility, enabling effective governance and escalation, and fostering prevention, transparency, and continuous improvement. Provide Strategic Site Compliance Leadership Bring an independent regulatory compliance perspective to significant site priorities and decisions, including: Inspection readiness and regulatory risk Product launch readiness and technology transfers Capacity expansion and facility modifications Major deviations, quality events, and data integrity concerns Supply continuity risks and enterprise compliance initiatives Potential regulatory reporting events, without assuming formal reportability decision ownership Drive Enterprise Thinking and Organizational Capability Connect significant site risks to platform and enterprise risks. Promote consistent risk identification, escalation, and cross-site learning. Support implementation of enterprise compliance priorities and transformation initiatives. Develop strong compliance talent and coach leaders on risk-based decision-making. Strengthen inspection-readiness capability and a culture of transparency, accountability, and prevention. Key Responsibilities 1. Compliance Risk Visibility & Site Risk Leadership Provide an independent regulatory compliance perspective on the site compliance-risk posture and support effective visibility, prioritization, escalation, and governance of significant risks. Relevant risk areas may include: Aseptic processing Cell culture operations Downstream purification

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Source: https://jobsbylevel.com/jobs/director-regulatory-compliance-biot-at-johnson-johnson-4a5cf1

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