Mgr Quality Assurance

Johnson & Johnson Innovative Medicine; Leiden; Vor Ort; EUR 69.000 - 120.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Volunteer leave

Well-being reimbursement

Career development

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality Management

GMP

ERP systems

MES systems

Digital quality governance

Leadership

Risk-based decision making

Regulatory inspections

BI / Business Intelligence

Communication (Dutch/English)

Ausbildung

Master’s degree in a relevant scientific or technical discipline

Tools

ERP systems

MES systems

Computerized system validation

Jobbeschreibung

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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

Job Sub Function

Job Category

All Job Posting Locations:

Leiden, South Holland, Netherlands

Job Description

Manager Quality Assurance – Operational Commercial Products

Location: Leiden, the Netherlands

Employment type: Full-time

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.

Required Skills

Preferred Skills:

Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Assessments, Standard Operating Procedure (SOP), Tactical Thinking, Team Management

The Anticipated Base Pay Range For This Position Is

€68 600,00 - €119 600,00

Benefits

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.