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Important Notice

We currently have three vacancies available for this position. We welcome applications from qualified candidates interested in joining our Quality Assurance organization.

We are searching for the best talent for anExperienced Specialist QA.

Purpose

We are looking for an enthusiastic and highly motivated Experienced Specialist QA to join the Quality Assurance team at Johnson & Johnson Innovative Medicine in Leiden The Netherlands.

The Quality Assurance department ensures that quality systems are applied in accordance with GMP requirements and supports activities such as deviation management CAPA product disposition change control and compliance oversight. The team plays an important role in providing quality guidance across the site and supporting the reliable supply of products to patients.

In this role you will provide Quality Assurance support to commercial manufacturing operations and act as a key quality partner for production facilities and Quality Control laboratories supporting Biological and/or Vaccine drug substance production. Working closely with Operations QC Warehouse Engineering and other site functions you will contribute to product quality GMP compliance investigation activities and continuous improvement efforts across the organization.

The work is varied collaborative and fast paced. This role is well suited to someone who enjoys solving complex problems working across functions and contributing to a strong compliance culture.

You will be responsible for

• Providing QA oversight to commercial manufacturing operations supporting Biological and/or Vaccine drug substance production
• Reviewing and assessing investigations participating in investigation teams and ensuring root cause analyses are thorough scientifically sound and completed in a timely manner
• Acting as a key contributor to non-conformance management including assessment of potential impact on product quality and GMP compliance
• Supporting and approving product disposition decisions for harvest intermediates process final bulk final bulk and drug substance products
• Providing clear practical and compliant advice regarding GMP and quality-related issues encountered during routine and non-routine operations
• Leading and supporting site investigations and helping ensure corrective and preventive actions (CAPAs) are effective sustainable and implemented within agreed timelines
• Escalating significant quality compliance and GMP issues to site and global management and coordinating escalation activities when required
• Supporting issues that may have an impact on product quality product supply or patient safety
• Participating in Quality Risk Management activities and root cause investigation sessions
• Reviewing assessing and approving deviation-related change controls
• Reviewing and approving document changes and change management activities
• Assessing reviewing and approving study protocols and reports to ensure work is conducted in accordance with cGMP and regulatory expectations including validation stability and analytical transfer activities
• Coordinating reviewing and supporting GMP training activities related to investigations deviations CAPA processes and non-conformance management
• Supporting inspection readiness activities and participating in regulatory inspections including FDA and EMA inspections
• Acting as a quality representative on local and global projects to ensure compliance with cGMP and company requirements
• Reviewing and approving maintenance notifications work orders maintenance and calibration documentation and associated data changes
• Supporting initiatives that strengthen quality and compliance awareness across the site including participation in GEMBA activities
• Identifying opportunities to improve compliance processes quality monitoring and operational effectiveness
• Participating in a rotating 24/7 on-call schedule and serving as the QA representative for critical quality compliance and GMP-related issues
• Partnering with site colleagues to ensure changes to manufacturing processes equipment systems and facilities are introduced in a controlled and compliant manner

Qualifications / Requirements

• Bachelors degree or higher in Biochemistry Biology Pharmaceutical Sciences Chemistry Biosciences or a related scientific field
• Minimum 6 years of experience in a GMP-regulated environment with a Bachelors degree or 4 years of experience with a Masters degree
• Experience in Quality Assurance Quality Control manufacturing operations or related pharmaceutical or biotechnology environments
• Up-to-date knowledge of GMP regulations and quality systems
• Experience with investigations root cause analysis CAPA management and quality risk management
• Understanding of cGMP requirements and applicable global regulations and guidelines including ICH FDA and EMA expectations
• Knowledge of deviation management change control validation and risk management processes
• Understanding of manufacturing operations laboratory processes facilities utilities and automation systems within a regulated environment
• Familiarity with Process Excellence Lean methodologies Co-Think Kepner-Tregoe or similar continuous improvement approaches is preferred
• Ability to assess risk and make balanced decisions while considering compliance requirements business needs and patient impact
• Strong communication collaboration negotiation and advisory skills
• Ability to influence and engage colleagues across functions and organizational levels
• Ability to work independently and manage multiple priorities in a dynamic environment
• Fluent in English both written and spoken
• Dutch language skills are considered an advantage
• 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

What we offer

We offer a collaborative environment where quality compliance and continuous learning are this role you will work closely with manufacturing laboratory and quality teams while contributing to the reliable supply of products that support patients around the world.

Our commitment to inclusion

We believe diverse perspectives experiences and backgrounds strengthen our teams and help us better serve patients around the world.

We are committed to creating an inclusive environment where everyone feels respected valued and supported. We welcome applications from qualified candidates of all backgrounds and experiences.

If you require reasonable accommodation during the recruitment process or while performing the role support is available throughout the process.

#LI-Hybrid

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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 locations 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.