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Specialist QA AT - Job Opportunity at Johnson & Johnson

Sassenheim, Netherlands
Full-time
Mid-level
Posted: July 3, 2025
On-site
EUR 55,000 - 75,000 annually. This estimate reflects the specialized nature of advanced therapy QA work in the Netherlands, where pharmaceutical companies typically offer competitive compensation packages. The salary range considers the 2-4 years experience requirement, the high-demand skillset in CAR-T manufacturing, and Johnson & Johnson's position as a premium employer in the pharmaceutical sector. The Netherlands market for specialized QA professionals commands higher salaries due to limited talent pool and increasing demand from biotech companies establishing European manufacturing operations.

Benefits

Opportunity to work on cutting-edge CAR-T therapy development, positioning yourself at the forefront of advanced cellular therapies that represent the future of cancer treatment
Access to global pharmaceutical leader's extensive resources and network, providing unparalleled professional development opportunities
Involvement in life-saving therapeutic manufacturing that directly impacts patient outcomes worldwide
Exposure to state-of-the-art lentivirus manufacturing processes and advanced therapy technologies
International collaboration opportunities with global quality teams across Johnson & Johnson's worldwide operations
Professional growth within a Fortune 500 company known for career advancement and internal mobility

Key Responsibilities

Drive strategic quality oversight for advanced therapy products, ensuring CAR-T manufacturing meets the highest regulatory standards that directly impact patient safety and treatment efficacy
Lead comprehensive GMP documentation review and approval processes that form the foundation of regulatory compliance and successful product launches
Execute critical validation activities including protocol and report reviews, CSV documentation, and change controls that ensure manufacturing reliability and product consistency
Manage complex release documentation for drug substances and raw materials, making quality decisions that determine product availability and patient access to life-saving therapies
Provide specialized quality oversight for aseptic processing operations, ensuring sterile manufacturing integrity that is crucial for patient safety in cellular therapy production
Champion continuous improvement initiatives to optimize QA processes, driving operational efficiency and quality excellence across the organization
Serve as subject matter expert for internal audits and regulatory inspections, protecting the company's reputation and ensuring continued manufacturing authorization
Maintain 24/7 quality oversight availability through rotation duties, demonstrating commitment to uninterrupted manufacturing operations and patient care continuity

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 advanced therapy medicinal products (ATMP) market is experiencing unprecedented growth, with CAR-T therapies leading the charge as one of the most promising cancer treatment modalities. The global CAR-T cell therapy market is projected to reach $20+ billion by 2030, driven by expanding indications beyond hematological malignancies into solid tumors. This growth is creating substantial demand for specialized quality assurance professionals who understand the unique manufacturing challenges of living cell therapies, including complex supply chain logistics, patient-specific manufacturing requirements, and stringent regulatory oversight. Regulatory agencies worldwide are intensifying their focus on advanced therapy manufacturing quality, with new guidelines emerging regularly for cell and gene therapy production. The FDA's recent emphasis on CMC (Chemistry, Manufacturing, and Controls) requirements for cell therapies, combined with EMA's advanced therapy classification procedures, is creating a specialized niche for QA professionals with lentivirus and CAR-T manufacturing expertise. Companies are investing heavily in building internal QA capabilities rather than relying solely on external consultants. The pharmaceutical industry is witnessing a significant shift toward personalized medicine, with CAR-T therapies representing the pinnacle of individualized treatment approaches. This trend is driving demand for QA professionals who can manage the complexities of patient-specific manufacturing, including chain of custody requirements, stringent timeline management, and quality oversight of autologous cell processing. The ability to ensure quality in a 'batch of one' manufacturing environment is becoming increasingly valuable. Digitalization and Industry 4.0 initiatives are transforming pharmaceutical manufacturing, with advanced therapies leading the adoption of electronic batch records, real-time quality monitoring, and predictive analytics. QA professionals with experience in computerized system validation (CSV) and digital quality management systems are particularly sought after, as companies seek to modernize their manufacturing operations while maintaining regulatory compliance.

Role Significance

The QA Advanced Therapies team likely consists of 8-12 professionals including specialists, senior specialists, and management, reflecting the specialized nature of CAR-T manufacturing quality oversight. The role involves close collaboration with cross-functional teams including Operations (15-20 people), Quality Control (10-15 people), and Manufacturing Science and Technology groups, creating a dynamic work environment with extensive internal networking opportunities.
This role represents a mid-level specialist position with significant quality decision-making authority and direct impact on product release and patient safety. The specialist operates with considerable autonomy in routine quality assessments while having clear escalation pathways for complex issues. The position serves as a bridge between junior QA associates and senior quality management, with opportunities to lead improvement initiatives and serve as a subject matter expert in regulatory interactions.

Key Projects

Implementation of new quality management systems and digital transformation initiatives to enhance manufacturing efficiency and compliance reporting Validation of new manufacturing equipment and processes as Johnson & Johnson expands its CAR-T production capabilities Regulatory preparation activities for health authority inspections and product license variations Continuous improvement projects focused on reducing manufacturing timelines while maintaining quality standards Cross-site harmonization initiatives to standardize quality procedures across Johnson & Johnson's global manufacturing network Technology transfer projects as new CAR-T products move from development to commercial manufacturing

Success Factors

Deep understanding of advanced therapy manufacturing principles and the unique quality challenges associated with living cell products, including maintenance of cell viability, potency, and sterility throughout the manufacturing process Strong regulatory knowledge and ability to interpret evolving guidelines from multiple health authorities, particularly FDA and EMA requirements for cell and gene therapies Excellent communication and collaboration skills to work effectively with diverse stakeholders including manufacturing operations, quality control laboratories, regulatory affairs, and external regulatory bodies Analytical mindset with strong problem-solving capabilities to investigate quality issues and implement effective corrective and preventive actions Adaptability and continuous learning orientation to stay current with rapidly evolving advanced therapy regulations and industry best practices Cultural sensitivity and language skills to work effectively in an international environment with colleagues from diverse backgrounds

Market Demand

Very High. The demand for QA professionals with advanced therapy manufacturing experience significantly exceeds supply, creating a candidate-driven market. Johnson & Johnson's investment in CAR-T manufacturing capabilities, combined with the broader industry expansion into cell and gene therapies, is generating numerous opportunities for qualified professionals. The specialized knowledge required for lentivirus manufacturing and CAR-T quality oversight makes this a highly sought-after skill set with excellent job security and career advancement potential.

Important Skills

Critical Skills

GMP knowledge and regulatory compliance expertise are absolutely essential as any quality failures in CAR-T manufacturing can have life-threatening consequences for patients and result in significant regulatory sanctions. The specialized nature of advanced therapy regulations requires deep understanding of both traditional pharmaceutical GMP principles and emerging cell therapy-specific requirements. Aseptic processing knowledge is critical because CAR-T manufacturing involves multiple sterile operations with living cells that cannot be terminally sterilized. Understanding contamination control, environmental monitoring, and sterile manufacturing principles is essential for ensuring product safety and efficacy. Strong analytical and problem-solving skills are vital because quality issues in CAR-T manufacturing often involve complex, multi-factorial problems requiring rapid resolution to prevent patient treatment delays. The ability to quickly assess situations and implement effective solutions directly impacts patient care. Communication skills are critical for interacting with diverse stakeholders including regulatory authorities, manufacturing teams, and clinical personnel. The ability to clearly explain complex quality concepts and regulatory requirements to non-QA personnel is essential for effective cross-functional collaboration.

Beneficial Skills

Dutch language skills would enhance local team integration and facilitate communication with Dutch regulatory authorities, though not mandatory given the international nature of the operation Project management capabilities would be valuable for leading continuous improvement initiatives and managing complex validation projects Statistical analysis skills would support trending activities and quality risk assessments Computer system validation experience would be beneficial given the increasing digitalization of manufacturing operations Regulatory affairs knowledge would enhance understanding of the broader regulatory landscape and support product registration activities Change management skills would be valuable for implementing process improvements and supporting organizational changes in a dynamic manufacturing environment

Unique Aspects

Opportunity to work on cutting-edge CAR-T therapy manufacturing, representing one of the most promising cancer treatment modalities with the potential to transform patient outcomes
Involvement in lentivirus manufacturing quality oversight, a highly specialized area with limited industry expertise and significant career value
Access to Johnson & Johnson's global quality network and best practices, providing exposure to world-class quality management systems and regulatory strategies
Participation in the development of quality standards for emerging therapeutic modalities, contributing to industry guidelines and regulatory frameworks
24/7 on-call responsibility demonstrating the critical nature of continuous quality oversight in life-saving therapy manufacturing
Cross-functional collaboration with multiple departments including global teams, providing extensive networking opportunities and business understanding

Career Growth

Career progression typically occurs within 3-5 years for high-performing individuals, with opportunities for advancement accelerated by the rapid growth in advanced therapy manufacturing. The specialized nature of CAR-T quality expertise can lead to faster promotion timelines compared to traditional pharmaceutical manufacturing roles.

Potential Next Roles

Senior QA Specialist Advanced Therapies with expanded responsibility for complex quality assessments and team leadership QA Manager Advanced Therapies leading a team of specialists and managing departmental strategy Regulatory Affairs Manager specializing in advanced therapy product registrations and health authority interactions Quality Systems Manager responsible for site-wide quality management system implementation and maintenance Manufacturing Quality Manager overseeing integrated quality operations across multiple product lines Global Quality Lead for Advanced Therapies with responsibility for worldwide quality strategy and standards

Company Overview

Johnson & Johnson

Johnson & Johnson represents one of the world's largest and most diversified healthcare companies, with a pharmaceutical division (Janssen) that has emerged as a leader in advanced therapy development and manufacturing. The company's commitment to CAR-T therapies, demonstrated through significant investments in manufacturing infrastructure and strategic partnerships, positions it at the forefront of the cellular therapy revolution. J&J's acquisition of advanced therapy capabilities and establishment of specialized manufacturing facilities reflects its long-term strategic commitment to this therapeutic area.

Johnson & Johnson maintains a dominant position in the global pharmaceutical market with consistent top-tier rankings in industry analyses. The company's financial stability, with annual revenues exceeding $90 billion, provides job security and resources for continued investment in advanced manufacturing technologies. J&J's reputation for quality and regulatory compliance excellence makes it a preferred employer for quality professionals seeking to work with industry-leading standards and practices.
The Netherlands facility in Sassenheim serves as a strategic European manufacturing hub for Johnson & Johnson's advanced therapy operations, reflecting the company's commitment to serving the European market with locally manufactured products. This location provides proximity to European regulatory authorities and access to the skilled European biotechnology workforce, while offering employees the opportunity to work on products that will be distributed across multiple European markets.
Johnson & Johnson is known for its strong emphasis on employee development, diversity and inclusion, and patient-focused mission. The company's credo-based culture emphasizes responsibility to patients, employees, communities, and shareholders in that order, creating a work environment that prioritizes quality and patient safety above short-term financial pressures. The collaborative, science-driven culture encourages innovation and continuous learning, with substantial investments in employee training and development programs.
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