Senior Manager, Process & Personnel Qualification

Biopharma Asia; Antwerpen; Hybrid; EUR 81,000 - 141,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Service anniversary / recognition

Job summary

Johnson & Johnson is seeking a Manager, Process & Personnel Qualification Management to lead PV process and training projects, driving compliance and quality in the pharmaceutical industry.

You will collaborate with the Innovative Medicines Office of the Chief Medical Officer and cross-functional teams, managing timelines, risks, and deliverables while supporting a digital transformation toward data-centric qualification management.

Qualifications

• Bachelor’s degree in Science or Business required, Master’s preferred.
• Minimum 5 years in a medium/large matrix organization with at least 5 years in pharmaceutical/device compliance.
• Strong English communication, both oral and written.
• Knowledge of global (pre)clinical safety and pharmacovigilance compliance regulations.
• Proven project management skills and ability to lead complex, cross-functional initiatives.
• Analytical mindset with attention to detail and ability to drive improvements.
• Demonstrated leadership, networking, and collaboration across teams.

Responsibilities

• Lead PV process and training projects, including process development, mapping, training development/qualification and delivery.
• Partner with IM OCMO and governance groups to ensure GxP Quality Framework adapts to changes.
• Manage tasks, timelines and deliverables; address issues and risks; provide updates to management.
• Support digital transformation roadmap toward data-centric content and robust qualification management.
• Lead or support audits, inspections, and other related activities as directed.

Skills

Business Process Management

Business Requirements Analysis

Coaching

Compliance Management

Cross-Functional Collaboration

Fact-Based Decision Making

ISO 9001

Process Governance

Process Improvements

Process Optimization

Quality Control

Quality Standards

Quality Validation

Stakeholder Engagement

SOP

Tactical Thinking

Education

Bachelor’s degree in Science or Business

Job description

Johnson & Johnson is seeking a Manager, Process & Personnel Qualification Management to lead PV process and training projects, driving compliance and quality in the pharmaceutical industry.

You will collaborate with the Innovative Medicines Office of the Chief Medical Officer and cross-functional teams, managing timelines, risks, and deliverables while supporting a digital transformation toward data-centric qualification management.