Mgr Quality Assurance

Johnson Johnson; Leiden; Presencial; EUR 90 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Flexible working arrangements

Global market leader

Dynamic working environment

Lead a new QA team

Resumo da oferta

Johnson & Johnson Leiden seeks a Manager Quality Assurance - Operational Commercial Products to lead a team of QA specialists ensuring quality oversight of commercial manufacturing and the supporting digital systems at the Leiden site.

You will collaborate with Operations, warehouse, QC labs, maintenance, and MSAT, driving quality leadership, governance for ERP/MES, and qualification activities. Strong Dutch/English communication and six years GMP experience are required.

Qualificações

• Master's degree in a relevant scientific or technical discipline.
• Six years of quality/GMP experience with at least two years in a managerial role.
• Knowledge of cGMP requirements and Quality Systems Pharma regulations (ICH, FDA and EMA).
• Experience with digitalization, BI, ERP/MES and computerized system validation.

Responsabilidades

• Lead, coach, and develop a team of QA specialists (8-12).
• Serve as the primary QA partner for Operations, Warehouse, and MSAT.
• Lead the resolution of complex quality and compliance issues.
• Maintain and improve GMP processes for commercial manufacturing and testing.
• Provide quality oversight for digital and computerized systems.
• Support inspection readiness and manage regulatory inspections.

Conhecimentos

Quality leadership

GMP knowledge

Risk-based judgment

Documentation & compliance

Dutch & English fluency

Digital systems knowledge

AI awareness

Stakeholder management

Team collaboration

Formação académica

Master's degree in a relevant scientific or technical discipline

Ferramentas

ERP systems

MES

Computerized System Validation

Descrição da oferta de emprego

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Quality

Job Sub Function

Quality Assurance

Job Category

People Leader

All Job Posting Locations

Leiden, South Holland, Netherlands

Job Title

Manager Quality Assurance - Operational Commercial Products

Location

Leiden, the Netherlands

Employment type

Full-time

Job Description

As Manager Quality Assurance - Operational Commercial Products (OCP), you will lead a team of QA specialists responsible for quality oversight of commercial manufacturing and its supporting digital systems at our Leiden site.

You will be part of the QA-OCP management team and will work in close collaboration with other departments (Operations, warehouse, QC labs, maintenance and MSAT). You will provide quality leadership and governance for digital and computerized systems supporting commercial operations, including Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), business intelligence solutions, computerized system validation, and qualification.

The role combines people leadership, operational quality oversight, stakeholder management, and digital quality governance. You are comfortable navigating complexity, addressing issues proactively, and working across multiple functions.

About the Company

Johnson & Johnson Innovative Medicine develops and manufactures innovative medicines for patients worldwide. At our Leiden site, Quality Assurance provides independent GMP oversight across manufacturing, laboratory, warehouse, maintenance, and supporting quality-system activities.

Your responsibilities

• Lead, coach, and develop a team of 8-12 QA specialists.
• Serve as the primary QA partner for Operations, Warehouse, QC Laboratories, Maintenance, and MSAT.
• Lead the resolution and escalation of complex quality and compliance issues.
• Maintain and improve GMP processes supporting commercial manufacturing and testing.
• Provide quality oversight for digital and computerized systems.
• Support inspection readiness programs and manage the process during Regulatory inspections.

What you bring

• Master's degree in a relevant scientific or technical discipline, such as biosciences, pharmacy, analytical chemistry, process technology, or engineering.
• Minimum of six years' experience in quality and/or similar GMP environment in pharmaceutical, consumer or medical device company, of which minimum two years in a managerial, people leading role.
• Strong quality mindset, sound risk-based judgment, and the ability to make and defend well-reasoned quality decisions.
• Knowledge of current Quality Management principles, cGMP requirements and Quality Systems Pharma regulations (ICH, FDA and EMA).
• Knowledge of digitalization, Business Intelligence, ERP systems, MES systems, computerized system validation and qualification.
• Perfect written and oral communication skills in Dutch and English.
• Team player, and ready to take a stand when necessary.
• Demonstrate an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and experience generating effective prompts to boost efficiency and productivity

What we offer

This is an opportunity to work with a highly motivated team and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement. We are passionate about our work; we play vital roles across a range of professional subject areas and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. Whether you're one of the ~2000 people who work here, or you're considering joining the team, we offer:

• Flexible working arrangements.
• Your chance to be part of a global market leader.
• A dynamic and inspiring working environment.
• The opportunity to establish and lead a new team within the Quality organization.
• Exposure to current and future biopharmaceutical manufacturing technologies.
• Access to an international network of quality and digital-system experts.
• Opportunities for continuous professional development.

Preferred Skills

• Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboratio