3x Experienced Specialist, QA – Quality in the Plant

Biopharma Careers; Leiden; Remote; EUR 75,000 - 110,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Leiden, Netherlands seeks an Experienced Specialist, QA to provide real-time quality assurance support on the manufacturing floor. You will strengthen GMP compliance, investigate deviations, and guide operations with independent QA oversight.

The role requires 6+ years in GMP environments, a science degree, and strong collaboration with MSAT, Engineering, and QC teams to ensure product quality and inspection readiness.

Qualifications

• Minimum 6 years of experience in a GMP-regulated environment with a Bachelor's degree, or 4 years 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.

Responsibilities

• Maintain an active QA presence in manufacturing areas during assigned shifts and observe GMP operations.
• Provide real-time quality guidance, support investigations, and manage non-conformances.
• Review GMP documentation, deviations, CAPAs, and change controls; support inspection readiness.
• Collaborate with Operations, MSAT, Engineering, and Quality Control to ensure compliance and continuous improvement.

Skills

Quality Assurance

GMP compliance

Investigations

CAPA

Change control

Risk management

Root cause analysis

MES / SAP

Education

Bachelor’s degree or higher in Biotechnology, Biology, Pharmacy, Chemistry, Life Sciences

Tools

MES

SAP

Job description

# 3x Experienced Specialist, QA – Quality in the PlantLeiden, Netherlands Full timeQualityNotify me about similar jobsView Full Job & Apply at Johnson & JohnsonJohnson & Johnson is the source of truth for this posting and owns the application process. We surface normalized context and market comparison you won't find on the original listing.## About this opportunityAt 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:**Professional**All Job Posting Locations:**Leiden, South Holland, Netherlands**Job Description:****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 shiftsObserve critical GMP and aseptic operations and provide real-time quality guidanceConduct routine floor walks, GMP observations, and GEMBA activitiesSupervise compliance with procedures, data integrity principles, contamination control requirements, and cleanroom behaviorsProvide 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 eventsSupport initiation, triage, containment, and escalation of non-conformancesParticipate in fact-finding activities and operator interviewsAssess quality impact and determine appropriate escalation pathwaysProvide real-time decision support to Operations while maintaining independent QA judgmentQuality Systems and ComplianceReview and approve GMP documentation, investigations, deviations, CAPAs, and change controls within the assigned scopeSupport inspection readiness activities across the siteParticipate in quality risk assessments and root cause investigationsContribute to improvements in quality systems and shop floor compliance processesHelp ensure compliance with applicable cGMP, FDA, EMA, ICH, and company requirements**Operational Integration**Participate in daily operational meetings, tier discussions, and shift handoversReview significant events and non-conformances from previous shiftsSupport MES exception management, material status activities, SAP-related quality processes, and Q-labeling activitiesBuild 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 operationsCoach operators and operational leaders on quality expectations and GMP requirementsSupport site initiatives focused on inspection readiness and ongoing process improvementServe as a role model for proactive quality engagement and collaborationThe 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 degreeExperience in Quality Assurance, Manufacturing Operations, Quality Control, or related pharmaceutical functionsExperience leading investigations, quality risk assessments, and compliance-related decision-makingExperience supporting aseptic processing or biologics manufacturing operations is strongly preferred**Knowledge & Skills**Strong understanding of GMP regulations and pharmaceutical manufacturing processesUnderstanding of manufacturing operations and shop floor processesExperience with deviation management, CAPA, change control, and risk management systemsStrong communication, coaching, and influencing skillsAbility to make risk-based quality decisions in a dynamic operational environmentExperience with MES, SAP, and digital manufacturing systems is preferredStrong analytical and problem-solving capabilitiesDemonstrates 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