Senior PQV Analyst — Combination Products (Quality)

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Sur place; EUR 73 000 - 115 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Well-being reimbursement

Insurance plans

Résumé du poste

Johnson & Johnson is seeking a PQV Combination Product Analyst IV to manage high-volume end-to-end quality complaint activities and MDR assessments across global sites.

You will lead investigations, guide cross-functional teams, ensure regulatory compliance, and provide SME support during audits; travel up to 5-10%.

Bachelor's or Master's in a technical field; strong QA and regulatory knowledge; English required; location in Europe (EMEA).

Qualifications

• Bachelor's or Master's degree in technical, scientific, or engineering disciplines.
• Experience in pharmaceutical/Medical Device QA or QC is preferred.
• Strong regulatory knowledge and ability to lead change initiatives.

Responsabilités

• Manage high-volume end-to-end complaint handling activities and MDR assessments.
• Lead cross-functional teams and provide guidance to PQV analysts.
• Ensure compliance with regulatory requirements and support audits.

Connaissances

Quality Assurance

Regulatory Knowledge

Project Leadership

Communication

Process Improvement

GxP Compliance

Auditing

Formation

Bachelor's or Master's degree in technical/scientific field

Outils

QMS

Description du poste

Johnson & Johnson is seeking a PQV Combination Product Analyst IV to manage high-volume end-to-end quality complaint activities and MDR assessments across global sites.

You will lead investigations, guide cross-functional teams, ensure regulatory compliance, and provide SME support during audits; travel up to 5-10%.

Bachelor's or Master's in a technical field; strong QA and regulatory knowledge; English required; location in Europe (EMEA).