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Specialist QA AT - Job Opportunity at Johnson & Johnson

Sassenheim, Netherlands
Full-time
Mid-level
Posted: July 1, 2025
On-site
EUR 65,000 - 85,000 annually, reflecting the specialized nature of advanced therapies quality assurance and the premium that biopharmaceutical companies pay for professionals with GMP experience in sterile manufacturing. The Netherlands market commands higher salaries due to talent scarcity in this emerging field.

Benefits

Access to cutting-edge cell and gene therapy technology development, positioning professionals at the forefront of revolutionary healthcare treatments
Opportunity to work with CAR-T therapy and Lentivirus manufacturing, which represents some of the most advanced therapeutic approaches in oncology
International collaboration opportunities with global departments across Johnson & Johnson's extensive network
Professional development in highly specialized GMP and advanced therapies quality assurance
Exposure to regulatory compliance for breakthrough therapies with accelerated approval pathways

Key Responsibilities

Lead comprehensive GMP documentation review and approval processes that directly impact product quality and patient safety across Johnson & Johnson's advanced therapy portfolio
Drive validation strategy execution through protocol and report approval, ensuring manufacturing processes meet the highest regulatory standards for life-saving therapies
Execute critical quality oversight for drug substance release documentation, serving as the final quality gate before materials advance to patient treatment
Manage complex maintenance and calibration approval workflows that maintain operational excellence in specialized manufacturing environments
Conduct strategic aseptic processing oversight activities that ensure sterile manufacturing integrity for cellular therapies
Orchestrate change management tracking and monitoring to prevent operational delays that could impact patient access to critical treatments
Lead periodic review assessments that maintain validated state compliance across utilities, equipment, and processes
Champion continuous improvement initiatives that standardize and optimize QA processes, driving operational efficiency
Serve as subject matter expert for internal audits and regulatory inspections, protecting company reputation and market access
Provide emergency quality oversight through on-call rotation, ensuring 24/7 manufacturing support for time-sensitive cellular therapies

Requirements

Education

Degree in science related subject and /or business-related area

Experience

2-4 years of experience in a GMP regulated environment (manufacturing, QA and/or QC) in a pharmaceutical company. QA experience preferred

Required Skills

Knowledge of current Quality Management principles, GMP and Quality Systems, Pharma regulations Knowledge of aseptic processing techniques and sterile manufacturing requirements is highly desired Strong written and verbal communication skills to effectively negotiate and interact with various stakeholders Problem solving, analytical thinking and decision making capabilities Demonstrated proficiency in English both in word and in writing. Dutch is a pre but not mandatory
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Sauge AI Market Intelligence

Industry Trends

The cell and gene therapy market is experiencing unprecedented growth, with the global CAR-T cell therapy market projected to reach $20.9 billion by 2030, driving massive demand for specialized quality assurance professionals who understand the unique manufacturing challenges of living medicines. This role positions professionals at the epicenter of this revolutionary healthcare transformation. Advanced therapy medicinal products (ATMPs) are increasingly becoming mainstream treatment options, with regulatory agencies like EMA and FDA streamlining approval pathways through breakthrough therapy designations and accelerated approvals, creating urgent need for QA specialists who can navigate these complex regulatory landscapes. The shift toward personalized medicine and autologous therapies is fundamentally changing manufacturing paradigms from large-scale batch production to individualized, time-sensitive manufacturing processes, requiring QA professionals with deep understanding of flexible manufacturing systems and real-time quality oversight capabilities. Biopharmaceutical companies are investing heavily in European manufacturing capabilities for advanced therapies, with the Netherlands emerging as a key hub due to its regulatory expertise and strategic location, creating significant career opportunities for QA professionals in this region.

Role Significance

Typically operates within a lean QA team of 8-12 specialists supporting advanced therapies operations, with matrix relationships across global quality networks and direct collaboration with manufacturing, warehouse, and regulatory affairs teams totaling 50+ stakeholders.
This mid-level specialist role represents a critical quality gatekeeper position with significant decision-making authority over product release and manufacturing operations, indicating substantial trust and responsibility within Johnson & Johnson's quality organization. The role's involvement in regulatory inspections and emergency response demonstrates its strategic importance to business continuity.

Key Projects

Implementation of digital quality systems and electronic batch record reviews for next-generation CAR-T manufacturing processes Validation of new Lentivirus manufacturing equipment and processes to support pipeline expansion Regulatory inspection readiness initiatives for FDA and EMA audits of advanced therapy manufacturing facilities Cross-functional quality improvement projects aimed at reducing manufacturing cycle times while maintaining sterility assurance Development of quality oversight procedures for emerging gene editing therapies and next-generation cellular products

Success Factors

Mastery of aseptic processing principles and sterile manufacturing environments is absolutely critical, as any contamination in cellular therapy manufacturing can result in patient safety risks and significant financial losses. Success requires the ability to think systematically about contamination control and environmental monitoring. Strong regulatory acumen and ability to interpret evolving guidance documents from FDA, EMA, and other global regulators is essential, as advanced therapies operate in a rapidly changing regulatory landscape where quality professionals must anticipate requirements before formal guidance is published. Exceptional attention to detail combined with the ability to work under pressure is crucial, given that many cellular therapies have extremely short shelf lives and manufacturing delays can directly impact patient treatment schedules and outcomes. Cross-functional collaboration skills are vital for success, as quality decisions often require input from manufacturing, clinical, regulatory, and commercial teams, requiring the ability to communicate complex technical concepts to diverse audiences and build consensus around quality standards.

Market Demand

Extremely high demand with limited qualified talent pool, as the intersection of advanced therapies expertise and traditional pharmaceutical QA experience creates a highly specialized skill set that commands premium compensation and rapid career advancement opportunities.

Important Skills

Critical Skills

Aseptic processing and sterile manufacturing knowledge is absolutely fundamental to success in this role, as cellular therapies require the highest levels of sterility assurance and any contamination events can result in product loss, patient safety risks, and significant regulatory scrutiny. This expertise is not easily acquired and represents a core differentiator in the advanced therapies job market. GMP documentation review and approval capabilities are essential daily requirements, as quality professionals must be able to quickly assess complex technical documents, identify potential compliance issues, and make decisions that balance regulatory requirements with operational efficiency. Strong documentation skills directly impact manufacturing productivity and regulatory inspection outcomes. Regulatory knowledge specific to advanced therapies is critically important, as this field operates under unique regulatory frameworks including expedited approval pathways, conditional approvals, and evolving guidance documents that require continuous learning and adaptation to maintain compliance and competitive advantage.

Beneficial Skills

Change management and project leadership skills become increasingly valuable as professionals advance to senior roles, where they must drive quality system improvements and lead cross-functional initiatives that impact multiple departments and global operations. Data analysis and trending capabilities are becoming more important as manufacturing operations generate increasing amounts of quality data that must be analyzed for continuous improvement opportunities and regulatory reporting requirements. Digital quality systems expertise provides competitive advantage as the industry continues to adopt electronic batch records, digital quality management systems, and data integrity technologies that improve efficiency and compliance.

Unique Aspects

This role offers direct exposure to Lentivirus manufacturing, which represents one of the most technically challenging aspects of CAR-T therapy production and provides specialized expertise that is highly valued across the entire advanced therapies industry.
The position includes emergency on-call responsibilities for manufacturing support, providing unique real-time problem-solving experience that accelerates professional development and demonstrates the critical nature of quality oversight in time-sensitive cellular therapy production.
Working at Johnson & Johnson's Netherlands facility provides exposure to both European regulatory requirements and global manufacturing standards, creating a comprehensive regulatory knowledge base that is highly transferable across international markets.
The role's involvement in both clinical and commercial manufacturing provides rare visibility into the complete product lifecycle from early development through commercial scale-up, offering insights into regulatory transition strategies and commercial manufacturing optimization.

Career Growth

Career progression to senior management roles typically occurs within 3-5 years for high-performing individuals in this rapidly expanding field, with exceptional opportunities for accelerated advancement due to the critical talent shortage in advanced therapies quality leadership.

Potential Next Roles

Senior QA Manager Advanced Therapies, typically leading teams of 5-8 QA specialists and taking ownership of site quality strategy for cellular and gene therapy operations Global Quality Director for Cell and Gene Therapy, overseeing quality operations across multiple manufacturing sites and leading regulatory strategy for product approvals Head of Quality Assurance for Emerging Technologies, responsible for establishing quality frameworks for next-generation therapies including gene editing and tissue engineering applications Regulatory Affairs Director specializing in advanced therapies, leveraging deep quality experience to guide regulatory strategy and agency interactions

Company Overview

Johnson & Johnson

Johnson & Johnson represents the world's largest and most diversified healthcare company, with pharmaceutical sales exceeding $50 billion annually and a commanding presence in the advanced therapies space through multiple CAR-T products and a robust pipeline of cellular and gene therapies. The company's Innovative Medicine division has invested over $3 billion in advanced therapy capabilities, positioning it as a global leader in this transformative treatment modality.

Johnson & Johnson maintains the #1 market position globally in pharmaceuticals and holds significant market share in the CAR-T therapy space, competing directly with Gilead/Kite, Novartis, and Bristol Myers Squibb. The company's financial strength and R&D investment of over $14 billion annually provides exceptional job security and growth opportunities.
The Netherlands operations represent a critical European hub for Johnson & Johnson's advanced therapies manufacturing and development, serving as the primary supply point for European markets and supporting global clinical trials. This strategic location provides exposure to both European regulatory requirements and global supply chain operations.
Johnson & Johnson's decentralized operating model empowers local teams with significant autonomy while providing access to global resources and expertise. The company's Credo-based culture emphasizes patient-first decision making, creating an environment where quality professionals are empowered to make decisions that prioritize patient safety over short-term business considerations.
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