Experienced Specialist Quality Systems & Compliance

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Sassenheim, Netherlands Job Description: We are searching for the best talent for an   Experienced Specialist, Quality Systems & Compliance . Purpose We are looking for an Experienced Specialist, Quality Systems & Compliance to join the Advanced Therapies Lentiviral Operations site in Sassenheim, the Netherlands. Are you interested in helping strengthen quality systems and compliance processes that support the delivery of advanced therapies to patients? In this role, you will support the execution and continuous improvement of core Quality Systems and Compliance activities across the site. Working closely with Quality Assurance, Operations, Quality Control, Technical Operations, and business partners, you will help ensure quality systems are effective, consistently executed, inspection ready, and aligned with GMP regulations, Johnson & Johnson standards, and site procedures. This position plays an important role in quality planning, management review, performance monitoring, risk management, inspection commitments, and quality system governance across the site. You will be responsible for In this role, you will contribute to Quality Systems and Compliance activities for the Advanced Therapies Lentiviral Operations site. You will help maintain visibility of site quality performance, support regulatory commitments, and ensure governance processes are completed in a timely and consistent manner. Working closely with Quality Assurance, Operations, Quality Control, Technical Operations, and site leadership, you will facilitate management review activities, maintain quality metrics, support risk management processes, and help ensure quality systems remain aligned with regulatory requirements and company standards. You will also contribute to audit and inspection activities, maintenance of site quality documentation, and management of quality system records. Through collaboration with cross-functional teams, you will help communicate compliance status, identify risks, monitor commitments, and support timely completion of actions. Key responsibilities include: Managing quality metrics and reporting activities for tier meetings, management reviews, review boards, and other site governance forums Facilitating Management Review Board activities, including preparation of presentations, meeting inputs, minutes, actions, extensions, and follow-up activities Maintaining the Site Risk Register, including risk reporting, meeting preparation, action tracking, and escalation of overdue or high-priority actions Managing compliance tracking activities, including inspection records, commitments, effectiveness checks, audit observations, and follow-up actions Supporting Site Quality Plan execution and tracking of commitments and related actions Supporting audit and inspection readiness activities, including inspection management support Coordinating periodic updates of the Site Master File, Quality Agreements, and related compliance documentation Acting as owner or reviewer for nonconformance, CAPA, change control,