Qualified Person

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: People Leader All Job Posting Locations: Sassenheim, Netherlands Job Description: 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. The Qualified Person provides QA support to the commercial and/or clinical Advanced Therapy (AT) products manufactured at the Sassenheim manufacturing site. Provides Quality oversight to the manufacture of API (Lentiviral) for commercial and clinical use and to the IPC, release and stability testing of AT products tested at the Leiden QC department. Provides independent reviews and ensure that a clear, pragmatic and quality driven advice is given regarding the state of GMP compliance. The Qualified Person works in close collaboration with other departments (e,g, Operations, QC, MSAT, Engineering, Warehouse and Development Departments). Reports to Sr. Manager QA and works together with and coaches QA specialists. Other internal contacts include colleagues, both at operational and managerial levels, and all departments within manufacturing site. External contacts: Quality and Non-Quality representatives within the Janssen Supply Chain (JSC) companies. Essential Job Duties and Responsibilities Provides Quality oversight to the production of Commercial and/or clinical AT Products (Lentiviral) at the site Assess and review the outcome of Quality Investigations, provide support as part of the investigation teams and monitor the quality of the Root Cause investigations. Assesses non-conformances for possible impact on product quality or compliance status and decide on product disposition (e.g., Harvest, Intermediates, (P)FB or Drug Substances). Escalates serious quality, compliance and /or GMP incidents to Site or Global Management Setup and coordinate Site and Global escalation meetings Provides Quality support for the development of appropriate Corrective and Preventative actions and provides Quality approval Ensures that the local Non-Conformance and CAPA programs are improved with gaining knowledge from the process Support (Global) escalation of issues, which have potential impact on the delivery of products to patients Participates in risk assessments to ensure compliance or quality is not jeopardized Coordinates, reviews, and provides GMP training (e.g., Non-conformances, Investigation techniques, CAPA etc.) for site colleagues to ensure compliance