Manager, Process & Personnel Qualification Management Expert

About the role

Johnson & Johnson is looking for a Manager, Process & Personnel Qualification Management Expert to join its Process & Data Management team in Allschwil, Switzerland. The role drives compliance and quality excellence in the pharmaceutical industry, leading process improvement projects and using digital tools to move from traditional processes and training toward a data-centric content and qualification management system.

Key responsibilities

• Lead Pharmacovigilance (PV) process and training projects, including process development, mapping and training development, qualification and delivery
• Act as a quality partner for the Innovative Medicines Office of the Chief Medical Officer, linking business partners, quality groups and governance so the GxP Quality Framework adapts proactively to business and regulatory change
• Manage tasks, timelines and deliverables, address issues, manage risks and give timely progress updates to management and business owners
• Support the digital transformation roadmap toward a data-centric content and qualification management system
• Support or lead additional projects, meetings and audits/inspections as directed

Required profile

• Bachelor's degree in Science or Business (Master's preferred)
• Minimum 5 years in a medium to large-scale matrix organization, with at least 5 years focused on pharmaceutical/device compliance; process design and training design experience preferred
• Exceptional oral and written English, able to explain complex ideas clearly
• Understanding of global (pre)clinical safety and pharmacovigilance regulations and the life sciences regulatory framework
• Proven project management, analytical, leadership and networking skills

Required skills

• Preferred: Business Process Management (BPM), Business Requirements Analysis, Compliance Management, ISO 9001, SOPs, Quality Control (QC), Quality Validation, Stakeholder Engagement
• Process governance, process improvements and optimization, cross-functional collaboration, fact-based decision making