Sr Anlst Quality Assurance

Johnson & Johnson Co.; Netherlands; On-site; EUR 64,000 - 103,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Volunteer leave

Well-being reimbursement

Health programs

Job summary

Johnson & Johnson is seeking a Senior QA Analyst – Technical QA to join our Quality Assurance team in Leiden, Netherlands. You will oversee qualification and validation lifecycles for equipment, systems, and facilities within pilot plant and QC labs, ensuring GMP compliance and a strong quality mindset across functions.

You will review validation deliverables, support CAPA activities, and collaborate with Manufacturing, Facilities, Engineering, Validation, QC and IT to implement compliant GMP

Qualifications

• Experience in QA oversight for qualification/validation lifecycles.
• Strong understanding of GMP requirements and quality systems.
• Ability to lead investigations, CAPA, change controls and risk assessments.

Responsibilities

• Provide QA oversight for qualification, validation lifecycle of equipment, systems and facilities.
• Review and approve validation deliverables (IQ/OQ/PQ) and reports.
• Ensure GMP compliance through QA support of events, investigations and CAPA.
• Serve as QA representative on cross-functional teams and drive site-wide quality initiatives.
• Collaborate with Manufacturing, Facilities, Engineering, QC and IT to implement compliant GMP systems.
• Support audit readiness and regulatory inspections; identify process improvements.

Skills

Quality Assurance

Regulatory Compliance

Risk Assessment

CAPA

GMP

Validation

Cross-functional Collaboration

Job description

Job Function: Quality

Job Sub Function: Quality Assurance

Job Category: Professional

All Job Posting Locations: Leiden, South Holland, Netherlands

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 Description

We are seeking a Senior QA Analyst – Technical QA to join our Quality Assurance team. In this role, you will provide QA oversight for the qualification and validation lifecycle of equipment, computerized systems, utilities, facilities, lab instruments and environmental conditions within our pilot plant and QC laboratories. We are looking for a highly motivated, independent professional with strong technical expertise, a quality mindset, and the ability to collaborate effectively across functions to ensure compliance with GMP requirements.

Key Responsibilities

• Provide Quality Assurance oversight for the qualification, validation, and lifecycle management of equipment, computerized systems, utilities, facilities, lab instruments and environmental controls supporting manufacturing and laboratory operations.
• Review and approve validation deliverables, including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, reports, and periodic review assessments
• Ensure compliance with GMP requirements by supporting and overseeing quality events, investigations, change controls, risk assessments, and corrective and preventive action (CAPA) activities.
• Serve as the Quality representative on cross-functional teams, providing strategic QA guidance and contributing to site-wide initiatives, projects, and continuous improvement efforts.
• Apply quality, scientific, and engineering principles to assess risks, solve complex technical and compliance challenges, and support informed decision-making.
• Collaborate with stakeholders across Manufacturing, Facilities, Engineering, Validation, QC, and IT to drive compliant implementation and lifecycle management of GMP systems and processes.
• Contribute to inspection readiness and support internal and external audits, regulatory inspections, and quality assessments.
• Identify opportunities to simplify, harmonize, and improve qualification, validation, and quality processes.

Required Skills: Preferred Skills:

• Business Alignment
• Business Savvy
• Coaching
• Communication
• Compliance Management
• Continuous Improvement
• Fact-Based Decision Making
• Human-Centered Design
• ISO 9001
• Issue Escalation
• Problem Solving
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Regulatory Environment
• Standard Operating Procedure (SOP)

Salary

The anticipated base pay range for this position is: €64 000,00 - €103 040,00

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
• employees - and in some location’s eligible dependents - can participate in several insurance plans.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change. At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.