Specialist Quality Assurance - QA NPD

Johnson & Johnson, Janssen Biologics B.V is recruiting for a Specialist Quality Assurance, located in Leiden, Netherlands

As a Specialist Quality Assurance - QA NPD, you will:

Provides QA support to the introduction, launch, and lifecycle transition of new products to the Leiden manufacturing site. Acts as the primary point of contact for new product–related quality topics within the site (e.g. development departments, clinical teams, production facilities and quality control laboratories). Provides Quality oversight to technology transfer, method and process qualification, PPQ, validation, and manufacture of API (Biologicals) and/or Drug Substances for clinical studies (Phase I–III), process performance qualification, and readiness for routine commercial manufacturing.

Provides independent review and ensures that clear, pragmatic, and quality‑driven advice is given regarding the state of GMP compliance throughout product introduction, scale‑up, and lifecycle activities. The Specialist Quality Assurance works in close collaboration with other departments (Operations, QC, Engineering, MSAT and Development Departments).

Reports to Sr Manager QA NPD & Launch and works closely with Specialist Quality Assurance and Experienced Specialist Quality Assurance colleagues. Other internal contacts include colleagues at both operational and managerial levels, and all departments within the manufacturing site. External contacts include Quality and Non‑Quality representatives within J&J Supply Chain (JSC) companies.

The responsibilities and the impact YOU will have:

• Participates as Core Team Member in New Product Introduction projects.
• Provides Quality oversight to the introduction of New Products to the site, including CTM, PPQ, and commercial readiness for routine manufacturing.
• Assesses and reviews Quality Investigations and non‑conformances, supports investigation teams, ensures robust root cause analysis, and determines product impact and disposition based on GMP and compliance considerations.
• Escalates serious quality, compliance and /or GMP incidents to Site or Global Management
• Supports Site and Global escalation meetings, as required.
• Provides Quality support for the development of appropriate Corrective and Preventive Actions (CAPAs) and provides Quality approval.
• Ensures that the local Non‑Conformance and CAPA programs are continuously improved through effective trending and knowledge sharing.
• Participates in risk assessments to ensure that compliance, quality, and patient safety are not jeopardized.
• Coordinates, reviews, and provides GMP training (e.g. Non‑conformances, investigation techniques, CAPA) to site colleagues to ensure compliance with cGMP and company training requirements.
• Participates in initiatives that foster a strong quality and compliance culture across the organization, including GEMBA walks in manufacturing areas and laboratories.
• Reviews and approves document changes and change controls.
• Optimizes existing processes and identifies new opportunities for process and quality monitoring
• On a rotation basis, is available 24/7 as QA representative for critical Quality issues.
• Acts as quality SME and supports preparation for, and participation during, inspections (e.g. FDA, EMA), including APR activities and inspection readiness, to ensure successful audits.
• Reviews and approves maintenance notifications and work orders, as applicable.
• Partners with site colleagues to ensure that all site changes (e.g. production processes, equipment, systems) are executed in a controlled and systematic manner and comply with cGMP and regulatory requirements.

Additional Duties & Responsibilities Quality Associate:

• Leads and supports the facility in identifying, assessing, and mitigating compliance risks across the product lifecycle.
• Acts as Quality representative and provides expertise in site and JBV projects to ensure compliance with cGMP and company quality standards.
• Assesses, reviews, and approves study protocols and reports to ensure that studies (e.g. stability, validation, analytical method transfer) are executed in a controlled and compliant manner.
• Acts as member of Quality Risk Management and/or root cause investigation sessions.

We would love to hear from YOU, if you have the following essential requirements:

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education.

Minimum experience required for the position:

• Depending on education, BSc 6 years and for MSc 4 years of experience in a GMP regulated environment (manufacturing, QA and/or QC)
• Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended.

Other Requirements

• Proven knowledge of the biotechnological/pharmaceutical industry
• Proficiency in English both in word and in writing
• 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.
• 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.
• Ability to drive collaboration in a fast-paced environment
• 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.

Preferred Skills:

Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards