QA Operations Lead – Digital GMP & Compliance

Johnson & Johnson Innovative Medicine; Leiden; On-site; EUR 69,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Volunteer leave

Well-being reimbursement

Career development

Job summary

Johnson & Johnson Innovative Medicine in Leiden, the Netherlands, seeks a Manager Quality Assurance – OCP to lead a team of QA specialists responsible for quality oversight of commercial manufacturing and its digital systems. You will collaborate across Operations, Warehouse, QC labs, Maintenance and MSAT to ensure GMP compliance.

You will provide governance for ERP, MES, BI solutions, and computerized system validation and qualification, drive inspections readiness, and mentor 8–12 staff

Qualifications

• Master’s degree in a relevant scientific or technical discipline.
• Minimum of six years’ experience in quality and/or GMP environments in pharma, consumer, or medical devices.
• At least two years in a managerial role leading people.
• Strong understanding of cGMP requirements and QMS standards (ICH, FDA, EMA).
• Experience with digitalization, ERP/MES, BI, and computerized system validation.
• Fluent written and spoken Dutch and English.

Responsibilities

• Lead, coach, and develop a team of 8–12 QA specialists.
• Partner with Operations, Warehouse, QC Labs, Maintenance, and MSAT.
• Resolve complex quality and compliance issues and drive CAPA when needed.
• Maintain and improve GMP processes supporting commercial manufacturing and testing.
• Provide quality oversight for digital and computerized systems.
• Support inspection readiness and regulatory inspections.

Skills

Quality Management

GMP

ERP systems

MES systems

Digital quality governance

Leadership

Risk-based decision making

Regulatory inspections

BI / Business Intelligence

Communication (Dutch/English)

Education

Master’s degree in a relevant scientific or technical discipline

Tools

ERP systems

MES systems

Computerized system validation

Job description

Johnson & Johnson Innovative Medicine in Leiden, the Netherlands, seeks a Manager Quality Assurance – OCP to lead a team of QA specialists responsible for quality oversight of commercial manufacturing and its digital systems. You will collaborate across Operations, Warehouse, QC labs, Maintenance and MSAT to ensure GMP compliance.

You will provide governance for ERP, MES, BI solutions, and computerized system validation and qualification, drive inspections readiness, and mentor 8–12 staff