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About the vacancy
Operations
Production
Production
Quality
Quality Assurance
Compliance
Quality Assurance
Compliance
Engineering
(Bio) Process
(Bio) Process
Staff
Project Management
Project Management
About Your Next Job
- Senior Specialist QA – Quality in the Plant at Johnson & Johnson Innovative Medicine in Leiden, The Netherlands
- Provide proactive, real-time Quality Assurance support within manufacturing operations
- Work closely with Operations and other site partners to strengthen GMP compliance, support investigations and deviations, provide quality guidance during manufacturing activities, and contribute to a strong quality culture
- Maintain an active presence within manufacturing operations and provide real-time quality support for commercial and clinical production activities
- Support manufacturing teams by providing quality guidance, assessing quality events, participating in investigations, and helping ensure appropriate escalation and risk management activities
About Your Next Colleagues
- You will join the Quality in the Plant team at Johnson & Johnson Innovative Medicine
- Work closely with Operations, Manufacturing Science & Technology (MSAT), Engineering, Warehouse, Quality Control, and Training functions
- Collaborate with site partners and operational leaders across manufacturing operations
About Your Tasks and Responsibilities
- 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
- 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
- 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
- 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
About Your Skills and Experience
- Strong Quality Assurance experience with a collaborative approach and the ability to make sound quality decisions in a fast-paced manufacturing environment
- Minimum of 8 years of experience in a GMP-regulated environment with a Bachelor's degree, or 6 years with a Master's degree, including at least 2 years in Quality Assurance and Manufacturing Operations
- 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
- Proven knowledge of the biotechnological/pharmaceutical industry and a thorough understanding of manufacturing operations and shop floor processes
- Deep understanding and application of Global Regulatory (cGMP/ICH/FDA/EMA) guidelines in Operations environment
- Functions independently in a complex environment to make daily judgment to balance business need, regulatory requirements, and cost efficiency for all Quality decisions
- Experience with deviation management, CAPA, change control, and risk management systems
- Strong communication, coaching, and influencing skills
- Ability to drive collaboration in a fast-paced environment
- Ability to make risk-based quality decisions in a dynamic operational environment
- Broad knowledge of QA systems (i.e., change control, deviation management, cGMP, validation) manufacturing and laboratory processes, facilities and utilities and technical automation
- Problem solving and troubleshooting to initiate fresh, innovative, and compliant solutions to manage unexpected quality issues
- Strong negotiation skills with a customer-oriented attitude
- Influences (without formal authority) and engages colleagues throughout the site and manages diversity and conflicting viewpoints
About Your Benefits
- 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
- 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
- Service anniversary and recognition awards
- Subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans
- The annual base pay includes an 8% holiday allowance
Where Molecules Meet Opportunities
- At 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
- 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
Only apply if...
- Bachelor’s degree or higher in Biotechnology, Biology, Pharmacy, Chemistry, Life Sciences, or another relevant scientific field
- Minimum of 8 years of experience in a GMP-regulated environment with a Bachelor's degree, or 6 years with a Master's degree
- At least 2 years of experience in Quality Assurance and Manufacturing Operations
- Experience in Quality Assurance, Manufacturing Operations, Quality Control, or related pharmaceutical functions
- Experience supporting aseptic processing or biologics manufacturing operations is strongly preferred
Contact person
Frank Helmus
At 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 https://www.jnj.com