Sr. Director, Sassenheim Quality Head & Global Lentivirus Operations

<p><span>At Johnson &amp; 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 https://www.jnj.com</span></p><p></p><p></p><p><b><span><span>Job Function: </span></span></b></p>Quality<p></p><p></p><p><b><span><span>Job Sub </span></span><span><span>Function: </span></span></b></p>Multi-Family Quality<p></p><p></p><p><b>Job Category:</b></p>People Leader<p></p><p></p><p><b>All Job Posting Locations:</b></p>Sassenheim, Netherlands<p></p><p></p><p><b>Job Description:</b></p><p>The Senior Director, Sassenheim Quality Head &amp; Lentivirus Platform Owner, is a strategic leadership role responsible for overseeing all Quality (QA/QC) functions at the Johnson &amp; Johnson Innovative Medicines Sassenheim site in Leiden, Netherlands. This role ensures strict compliance with cGMP standards and Janssen’s quality requirements, while establishing and maintaining robust Quality standards and systems across the site. The leader develops and executes long-term Quality strategies, driving a reliable supply of high-quality products for both clinical and commercial use through the J&amp;J Supply Chain. Additionally, this role manages a team of QA &amp; QC professionals, fostering a culture of excellence and continuous improvement.  Beyond site-specific responsibilities, the role serves as the Quality partner to the Autologous Lentivirus Operations leader, focusing on compliantly expanding and scaling the global lentivirus supply chain across multiple locations in Raritan, Bern, and Sassenheim. This includes driving global consistency in Quality Operations and implementing structural and process changes to support scalable, compliant production.</p><p></p><p><u><b>You will be responsible for:</b></u></p><p></p><p><b><i>Sassenheim Site Quality Management Responsibilities</i></b></p><ul><li><p>Provides overarching leadership for cGMP operations (clinical and commercial) at the Sassenheim lentivirus cell therapy manufacturing facility, ensuring compliance with applicable regulations and J&amp;J policies for CAR-T and lentiviral processes.</p></li><li><p>Guides QA &amp; QC teams to ensure the effectiveness of the Quality Management System (QMS) and GMP compliance across all manufacturing activities.</p></li><li><p>Establishes and maintains a robust QMS aligned with Janssen’s quality objectives and regulatory standards.</p></li><li><p>Participates in management reviews, evaluating process performance, product quality, and QMS effectiveness to foster continuous improvement.</p></li><li><p>Ensures proper resource allocation, effective communication, and escalation of quality issues to senior management.</p></li><li><p>Implements and maintains processes, procedures, and systems to support compliant manufacturing, testing, and distribution.</p></li><li><p>Provides expertise on global health authority regulations, guiding interpretation and application to ensure ongoing compliance.</p></li><li><p>Acts as the primary site representative during health authority inspections, leading internal and regulatory audits and fostering strong regulator relationships.</p></li><li><p>Monitors and analyzes regulatory activities and guidance, advising leadership on potential impacts and opportunities.</p></li><li><p>Oversees quality assurance programs to ensure all products are safe, effective, and compliant throughout their lifecycle.</p></li><li><p>Develops and executes strategies for the Site Quality Organization, including QA, Quality Systems, and related functions, aligned with site goals.</p></li><li><p>Serves as process owner for Product Quality Review and Management Review processes, establishing KPIs to monitor and improve operational performance.</p></li><li><p>Ensures continuous training and development of quality personnel to meet evolving business and regulatory needs.</p></li><li><p>Authorizes and maintains documentation, including SOPs and amendments, to ensure clarity and compliance.</p></li><li><p>Approves and monitors suppliers, contract manufacturers, and outsourced GMP activities to uphold quality standards.</p></li></ul><p></p><p><b><i>Delegation of Authority</i></b></p><ul><li><p>Acts as a deputy for the Qualified Person, with decision authority on product release, rejection of non-conforming products, and other quality-related matters, independently from management.</p></li></ul><p></p><p><b><i>Global Lentivirus Operations</i></b></p><ul><li><p>Ensures consistent application of quality standards and practices across Bern, Raritan, and Sassenheim sites, promoting harmonization of processes, system