3x Experienced Specialist, QA – Quality in the Plant

 Bij Johnson & Johnson geloven we dat gezondheid alles is. Onze kracht op het gebied van innovatie in de gezondheidszorg stelt ons in staat een wereld op te bouwen waar complexe ziekten worden voorkomen, behandeld en genezen, waar behandelingen slimmer en minder invasief zijn en oplossingen persoonlijk zijn. Dankzij onze expertise op het gebied van innovatieve geneeskunde en MedTech bevinden we ons in een unieke positie om vandaag de dag te innoveren in het volledige spectrum van zorgoplossingen om de doorbraken van morgen te realiseren en een grote impact te hebben op de gezondheid van de mensheid. Ga voor meer informatie naar jnj.com

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Functie:

Quality

Subfunctie functie:

Quality Assurance

Functiecategorie:

Professional

Alle vacaturelocaties:

Leiden, South Holland, Netherlands

Functieomschrijving:Functieomschrijving:

There are currently three openings available for this position. We welcome applications from qualified candidates who are interested in joining our team.

We are searching for the best talent for an Experienced Specialist, QA – Quality in the Plant.

Purpose

We are looking for an Experienced Specialist, QA to join the Quality in the Plant team at Johnson & Johnson Innovative Medicine in Leiden, The Netherlands.

In this role, you will provide proactive, real-time Quality Assurance support within manufacturing operations. Working closely with Operations and other site partners, you will help strengthen GMP compliance, support investigations and deviations, provide quality guidance during manufacturing activities, and contribute to a strong quality culture.

As a visible and trusted quality partner on the shop floor, you will help ensure quality is built into operations from the start while maintaining independent QA oversight and decision-making.

You will be responsible for

In this role, you will maintain an active presence within manufacturing operations and provide real-time quality support for commercial and clinical production activities. Working closely with Operations, Manufacturing Science & Technology (MSAT), Engineering, Warehouse, Quality Control, and Training functions, you will help ensure compliance with GMP requirements, regulatory expectations, and company standards.

You will support manufacturing teams by providing quality guidance, assessing quality events, participating in investigations, and helping ensure appropriate escalation and risk management activities are in place. The role also supports inspection readiness, quality culture initiatives, and continuous improvement efforts across the site.

Shop Floor Quality Oversight

• Maintain an active QA presence in manufacturing areas during assigned shifts
• Observe critical GMP and aseptic operations and provide real-time quality guidance
• Conduct routine floor walks, GMP observations, and GEMBA activities
• Supervise compliance with procedures, data integrity principles, contamination control requirements, and cleanroom behaviors
• Provide quality oversight for critical process steps and witnessing activities within the site Process Confirmation Program

Real-Time Quality Support

• Act as first-line QA support for manufacturing quality-related questions and events
• Support initiation, triage, containment, and escalation of non-conformances
• Participate in fact-finding activities and operator interviews
• Assess quality impact and determine appropriate escalation pathways
• Provide real-time decision support to Operations while maintaining independent QA judgment

Quality Systems and Compliance

• Review and approve GMP documentation, investigations, deviations, CAPAs, and change controls within the assigned scope
• Support inspection readiness activities across the site
• Participate in quality risk assessments and root cause investigations
• Contribute to improvements in quality systems and shop floor compliance processes
• Help ensure compliance with applicable cGMP, FDA, EMA, ICH, and company requirements

Operational Integration

• Participate in daily operational meetings, tier discussions, and shift handovers
• Review significant events and non-conformances from previous shifts
• Support MES exception management, material status activities, SAP-related quality processes, and Q-labeling activities
• Build strong collaborative relationships with Operations, MSAT, Engineering, Warehouse, Quality Control, and Training functions

Quality Culture and Coaching

• Promote quality ownership and GMP excellence across manufacturing operations
• Coach operators and operational leaders on quality expectations and GMP requirements
• Support site initiatives focused on inspection readiness and ongoing process improvement
• Serve as a role model for proactive quality engagement and collaboration

The role enables Operations to make compliant decisions while maintaining clear Quality oversight and independence.

Qualifications / Requirements

We are looking for someone who combines strong Quality Assurance experience with a collaborative approach and the ability to make sound quality decisions in a fast-paced manufacturing environment.

Education

• Bachelor’s degree or higher in Biotechnology, Biology, Pharmacy, Chemistry, Life Sciences, or another relevant scientific field

Experience

• Minimum 6 years of experience in a GMP-regulated environment with a Bachelor's degree, or 4 years of experience with a Master's degree
• Experience in Quality Assurance, Manufacturing Operations, Quality Control, or related pharmaceutical functions
• Experience leading investigations, quality risk assessments, and compliance-related decision-making
• Experience supporting aseptic processing or biologics manufacturing operations is strongly preferred

Knowledge & Skills

• Strong understanding of GMP regulations and pharmaceutical manufacturing processes
• Understanding of manufacturing operations and shop floor processes
• Experience with deviation management, CAPA, change control, and risk management systems
• Strong communication, coaching, and influencing skills
• Ability to make risk-based quality decisions in a dynamic operational environment
• Experience with MES, SAP, and digital manufacturing systems is preferred
• Strong analytical and problem-solving capabilities
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

Additional Role Information

The position will initially operate within a daytime schedule to support onboarding, qualification, and process familiarization.

Following implementation of the Quality in the Plant operating model, the role will transition to a 16/7 shift organization supporting manufacturing operations through:

• Early Shift: 07:00 – 15:30
• Late Shift: 15:00 – 23:30

The specialist will work across shift teams, participate in structured shift handovers, and provide ongoing quality oversight during extended manufacturing operations.

What we offer

We offer a collaborative environment where learning, innovation, and professional development are encouraged.

In this role, you will have the opportunity to work directly with manufacturing teams, strengthen quality within operations, and contribute to products that make an important difference for patients.

Our commitment to inclusion

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives.

We are proud to be an equal opportunity employer and welcome applications from qualified candidates of all backgrounds.

If you require a reasonable accommodation during the application, interview, or onboarding process, support is available. Please let us know how we can help.

#LI-Onsite

 

 

Vereiste vaardigheden:

 

 

Gewenste vaardigheden:

Behalen van het doel, Business alignment, Coachen, Compliancebeheer, Continue verbetering, Detailgericht, Gegevensanalyse, Interne controles, Kwaliteitsbeheersystemen (QMS), Kwaliteitscontrole (QC), Kwaliteitsnormen, Mensgericht ontwerpen, Probleemescalatie, Probleemoplossend, Procesgeoriënteerd, Zakelijk gedrag

  

 

Het te verwachten bruto jaarsalaris voor deze functie ligt tussen de:

€53 500,00 - €85 445,00

 

 

Voordelen:

Naast het basissalaris bieden wij de volgende benefits*: Een jaarlijkse bonus met een vast percentage (% van het salaris) afhankelijk van de salarisschaal / land, waarbij het werkelijke bedrag is gebaseerd op de prestaties van de werknemer en de onderneming in het voorgaande kalenderjaar, of verkoopcommissies. Bovendien bieden wij vakantiedagen, minimaal 12 weken ouderschapsverlof, verlof bij overlijden van directe familie, zorgverlof, vrijwilligersverlof en welzijns programma's voor financiële, fysieke en geestelijke gezondheid. We bieden ook jubileum- en erkenningsbeloningen aan en afhankelijk van de voorwaarden van hun respectieve plannen, kunnen medewerkers - en in sommige locaties hun aanverwanten - deelnemen aan verschillende verzekeringsplannen. Ga voor meer informatie naar Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*dit is alleen voor informatieve doeleinden. Bedragen en werkelijke benefits kunnen per land verschillen en kunnen worden gewijzigd.