Senior PQV Combination Product Quality Analyst

Biopharma Careers; Antwerpen; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

Johnson & Johnson is seeking a PQV Combination Product Analyst 4 to manage high-volume E2E complaint activities and MDR assessments across global sites. You will collaborate with Safety, QA, Manufacturing, IT, and external partners to ensure accurate investigations and timely regulatory reporting.

The role requires a Bachelor’s or Master’s in a technical/scientific field, 5+ years in QA/QC, and strong knowledge of MDR, GMP, and ISO standards. Travel up to 5–10% may be needed.

Qualifications

• 5+ years of related experience in QA/QC in pharma or medical devices
• Strong knowledge of regulatory requirements (GMP, GLP, ISO 13485, ISO 14971)
• Experience with MDR/medical device reporting and CAPA processes
• Ability to lead change initiatives and project teams
• Excellent communication and stakeholder management skills

Responsibilities

• Handle high-volume end-to-end complaint handling activities and MDR assessments
• Evaluate complaints for MDR reportability and coordinate investigations
• Provide guidance to PQV peers and interact with regulatory authorities as SME
• Lead process improvements and change-management initiatives across sites
• Support internal and external audits and regulatory inspections

Skills

Quality Assurance

Quality Control

Regulatory knowledge

Project management

Communication

Education

Bachelor's or Master’s degree in technical/scientific disciplines

Job description

Johnson & Johnson is seeking a PQV Combination Product Analyst 4 to manage high-volume E2E complaint activities and MDR assessments across global sites. You will collaborate with Safety, QA, Manufacturing, IT, and external partners to ensure accurate investigations and timely regulatory reporting.

The role requires a Bachelor’s or Master’s in a technical/scientific field, 5+ years in QA/QC, and strong knowledge of MDR, GMP, and ISO standards. Travel up to 5–10% may be needed.