Senior PQV Product Quality Analyst - MDR & Complaints

Biopharma Careers; Beerse; On-site; EUR 90,000 - 120,000; Full time

Job summary

Johnson & Johnson is seeking a PQV Analyst IV to manage high-volume complaint handling and MDR assessments across multiple sites. You will lead regulatory reporting, risk assessment and change management, collaborating with global teams to ensure timely, compliant processes.

The role requires strong project leadership and analytics skills, with experience in GMP/GDP environments and support for internal audits and inspections.

Qualifications

• Bachelor’s or Master’s degree in technical/science fields.
• Strong knowledge of regulatory requirements (GxP, MDR) and quality systems.
• Experience leading/participating in end-to-end complaint handling and MDR processes.

Responsibilities

• Perform high-volume end-to-end complaint handling and MDR assessments.
• Lead cross-functional governance to ensure data integrity and KPI achievement.
• Provide SME guidance during regulatory inspections and CAPA activities.

Skills

Quality Assurance

Regulatory compliance

Project leadership

Data analysis

Communication

Education

Bachelor’s degree in technical/engineering

Tools

QMS systems

GxP software

Job description

Johnson & Johnson is seeking a PQV Analyst IV to manage high-volume complaint handling and MDR assessments across multiple sites. You will lead regulatory reporting, risk assessment and change management, collaborating with global teams to ensure timely, compliant processes.

The role requires strong project leadership and analytics skills, with experience in GMP/GDP environments and support for internal audits and inspections.