Director, Regulatory Compliance - BioT

About the role

Johnson & Johnson is recruiting a Director, Regulatory Compliance for its Biotherapeutics (BioT) site in Schaffhausen, reporting to the Senior Director of Regulatory Compliance, Large Molecule. This is the senior site-based compliance leader, responsible for independent compliance leadership, keeping the site's compliance-risk posture visible, promoting inspection readiness, enabling timely escalation and strengthening organisational learning. The role partners with Site Leadership, Quality, Manufacturing, MSAT, Engineering, Supply Chain, Regulatory Affairs and Quality Control.

Key responsibilities

• Provide an independent regulatory compliance perspective on site priorities such as inspection readiness, product launch readiness, capacity expansion, major deviations, quality events, supply continuity and potential regulatory reporting events.
• Strengthen inspection readiness and risk visibility, promote consistent risk identification, escalation and cross-site learning, and support enterprise compliance priorities.
• Lead compliance oversight of biotherapeutics manufacturing, including upstream and downstream operations, sterile operations, utilities, environmental monitoring, process validation, CPV, technology transfers and product launches.
• Build and develop a high-performing site compliance organisation, recruit and coach staff, set performance objectives, build compliance analytics and regulatory strategy capability, and develop succession plans.

Required profile

• Bachelor's degree in Biotechnology, Biological Sciences, Pharmacy, Engineering, Chemistry, Microbiology, Biochemistry or a related scientific discipline; advanced degree preferred.
• 12+ years of pharmaceutical or biotechnology experience and 5+ years of leadership experience.
• Significant experience in biologics manufacturing, quality, compliance or regulatory oversight.
• Experience supporting FDA, EMA, MHRA, PMDA or other global health authority inspections.

Required skills

• Strong understanding of biologics manufacturing, aseptic processing, cell culture and downstream processing, Annex 1 requirements, process validation, data integrity, quality systems, sterility assurance, contamination control, technology transfers and commercialisation.
• Preferred: compliance management, agile internal audit, compliance frameworks, policies, developing others, leadership and risk management.