Experienced Specialist QA

• Experience with methodologies such as Process Excellence, Co-Think, Kepner-Tregoe, or similar approaches is preferred

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

We are looking for someone who combines strong quality expertise, sound judgment, and the ability to work effectively across a complex and highly regulated environment.

• Bachelor's degree or higher in Biochemistry, Biology, Pharmaceutical Sciences, or another relevant scientific field

• Fluent in English

We offer a collaborative environment where learning, innovation, and professional development are encouraged. This role provides opportunities to contribute to Advanced Therapies manufacturing, collaborate across multiple functions, and support products that can make a meaningful difference for patients.

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.

We are searching for the best talent for an Experienced Specialist, QA.

€53 500,00 - €85 445,00

• Providing oversight for Advanced Therapies production activities at the site
• Providing quality guidance for GMP processes including Change Control, Document Control, GMP Training, and inspection readiness
• Providing quality guidance for facility, utility, and equipment design activities, including new facility projects
• Supporting technology transfers, analytical transfers, qualification programs, and validation activities
• Supporting aseptic processing operations and Annex 1 compliance requirements
• Reviewing and assessing Quality Investigations and monitoring the quality of root cause investigations
• Assessing non-conformances for potential impact on product quality or compliance status and supporting product disposition decisions
• Reviewing and approving appropriate Corrective and Preventive Actions (CAPAs)
• Escalating significant quality, compliance, or GMP issues and supporting local and global escalation activities where patient supply may be impacted
• Participating in hazard assessments and Quality Risk Management activities
• Coordinating, reviewing, and delivering GMP training activities related to investigations, qualifications, and non-conformance management
• Supporting quality culture initiatives across manufacturing and laboratory operations, including GEMBA activities
• Reviewing and approving document changes and change controls
• Leading or participating in local and global quality and capacity projects
• Enhancing process monitoring and quality monitoring approaches
• Acting as a Quality SME during inspection preparation activities and supporting FDA, EMA, and other regulatory inspections
• Supporting Annual Product Reviews (APR), inspection readiness reports, and related compliance activities
• Partnering with site colleagues to ensure changes to manufacturing processes, equipment, facilities, and systems are implemented in a controlled and compliant manner
• Participating in a rotating 24/7 on-call schedule as the QA representative for quality-related issues

As an Experienced Specialist, QA, you will also represent Quality in Advanced Therapies projects, support identification and mitigation of compliance risks, review and approve study protocols and reports, and participate in Quality Risk Management and root cause investigation sessions.

Quality

Quality Assurance

Professional

Sassenheim, Netherlands

We are looking for an Experienced Specialist, QA to join our Advanced Therapies (AT) Quality Assurance team in Leiden/Sassenheim, The Netherlands.

Are you interested in helping ensure the delivery of advanced therapies by strengthening GMP compliance, quality oversight, and inspection readiness in a highly regulated manufacturing environment?

In this role, you will provide Quality Assurance support for commercial and clinical manufacturing activities at the Advanced Therapies manufacturing site. Acting as a key quality partner for production facilities and Quality Control laboratories, you will provide oversight for the manufacture of drug substances and starting materials while helping ensure compliance with GMP requirements, company standards, and regulatory expectations.

Working closely with Operations, Quality Control, Warehouse, Manufacturing Asset Management (MAM), Manufacturing Science & Technology (MSAT), and other business partners, you will provide independent review and pragmatic quality guidance to support compliant decision-making, continuous improvement, and reliable product supply.

We look forward to hearing from you!

In this role, you will provide Quality Assurance oversight for Advanced Therapies manufacturing operations and help ensure products, processes, equipment, and systems operate in accordance with GMP requirements and regulatory expectations.

You will assess investigations, participate in risk management activities, provide quality guidance on manufacturing and support processes, and help maintain a state of inspection readiness across the site. The role includes partnering closely with cross-functional teams to support compliant operations, identify potential risks, and contribute to the continuous strengthening of quality systems and manufacturing processes.

You will also support key GMP activities including qualifications, validations, technology transfers, analytical transfers, aseptic processing, Annex 1 adherence, facility and equipment projects, and change management programs.

• Minimum 6 years of experience in a GMP-regulated environment with a Bachelor's degree, or 4 years of experience with a Master's degree
• Experience within Quality Assurance, Quality Control, manufacturing operations, or related pharmaceutical or biotechnology environments
• Proven knowledge of the biotechnology and/or pharmaceutical industry

• Strong understanding of global regulatory requirements, including cGMP, ICH, FDA, and EMA expectations
• Knowledge of Quality Systems including change control, deviation management, CAPA, validation, and risk management
• Understanding of manufacturing processes, laboratory operations, facilities, utilities, and technical automation systems
• Experience supporting investigations, troubleshooting activities, and development of compliant solutions to quality issues

• Ability to work independently and make risk-based decisions in a complex environment
• Strong analytical, problem-solving, and decision-making skills
• Ability to balance business needs, regulatory requirements, quality expectations, and patient impact
• Strong collaboration, influencing, and negotiation skills
• Ability to engage partners and navigate differing viewpoints effectively
• Strong communication skills, both written and verbal
• 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

• Location: Leiden/Sassenheim, The Netherlands
• Participation in a rotating 24/7 on-call schedule is required
• Close collaboration with Operations, QC, Warehouse, MAM, MSAT, and Quality functions is expected
• Support for regulatory inspections and audits may be required as part of normal responsibilities