GMP Quality Systems Lead — Audit & Compliance (12 Mo)

Johnson & Johnson; Leiden; On-site; EUR 110,000 - 130,000; Full time

Job summary

Johnson & Johnson in Leiden seeks a QA Specialist for GMP System Data Integrity on a 12‑month, 40‑hour week contract. You will uphold and improve core quality systems, ensuring compliance with global standards across a multi-site organisation.

The role requires deep GMP knowledge, strong analytical and leadership skills, and fluency in English. You will interact with regulatory bodies, internal teams, and external partners to maintain inspection readiness and data integrity.

Qualifications

• Master’s degree or equivalent in bioscience, pharmacy or related field.
• Extensive knowledge of Quality Systems in a cGMP environment (Annex 11).
• Advanced courses on cGMP Internal practices.
• Experience in Process Excellence/Lean, Risk Management and Auditing is a plus.
• 8–10 years in pharmaceutical or related industry with quality/compliance focus.
• Experience in a complex multinational environment with strong analytical thinking.
• Proven leadership and advisory capabilities; effective communicator.

Responsibilities

• Act as a Center of Expertise for GMP core quality systems and improve them.
• Ensure consistency of quality systems across processes and departments.
• Translate GMP regulations and Janssen/J&J standards into compliant JBV systems.
• Lead Inspection Readiness programs for GMP compliance and inspections.
• Perform internal audits, identify improvements, and drive compliance initiatives.
• Utilize PE, Lean, and Risk Management tools to assess and improve quality processes.
• Develop GMP training programs and ensure effective training across teams.
• Serve as Quality contact for core systems with international stakeholders.
• Maintain networks to identify best practices and ensure regulatory alignment.
• Communicate updates to management and ensure timely reviews.

Skills

Analytical thinking

Leadership

Communication

English fluency

Education

Master’s degree or equivalent in bioscience/pharmacy

Job description

Johnson & Johnson in Leiden seeks a QA Specialist for GMP System Data Integrity on a 12‑month, 40‑hour week contract. You will uphold and improve core quality systems, ensuring compliance with global standards across a multi-site organisation.

The role requires deep GMP knowledge, strong analytical and leadership skills, and fluency in English. You will interact with regulatory bodies, internal teams, and external partners to maintain inspection readiness and data integrity.