Senior Specialist QA - Quality in the Plant

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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 a Senior Specialist, QA – Quality in the Plant.

Purpose

We are looking for a Senior 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

• A 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

Knowledge & Skills

• 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. Is required to determine the level of risk, magnitude and/or complexity in order to make sound judgment on when to escalate critical issues to Quality management.
• 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.
• Has good negotiation skills with a customer-oriented attitude. Influences (without formal authority) and engages colleagues throughout the site and manages diversity and conflicting viewpoints.
• Empowered professional who can make well motivated pragmatic decisions on their own.

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.

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Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

Benefits:

In addition to base pay, we offer the following benefits*: an 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. Moreover, we offer 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. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Additional information:

The Netherlands: 8%.The annual base pay includes an 8% holiday allowance.

Het bruto jaarsalaris is inclusief vakantietoeslag van 8%.