QA-CSC Director & IMP Qualified Person

QA-CSC Director & IMP QP Within Janssen R&D, a member of Johnson & Johnson's Family of Companies, we are recruiting a QA-CSC Director & IMP Qualified Person (QP) based in Belgium. In the Janssen Research & Development area we develop treatments that improve the health and lifestyles of people worldwide. R&D development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, pulmonary hypertension and reproductive medicine. The QA-Clinical Supply Chain (QA-CSC) department is responsible for the release and certification of Investigational Medicinal Products (IMP) used in worldwide clinical trials guaranteeing product quality and compliance with applicable regulations. Objectives and responsibilities Leading the IMP QP team responsible for ensuring that each batch of IMP has been manufactured in compliance with GMP and ensuring regulatory compliant and timely release of IMP in support of a reliable clinical supply chain. The IMP QP teams includes a team of Early Development Product Quality Integrators/QPs responsible for the overall end-to-end quality strategy and release Acting as Qualified Person (QP) as per legislation for GMP Manufacturing and Importation Authorisation (MIA) IMP of Janssen Research & Development, a division of Janssen Pharmaceutica NV, including: batch certification of Investigational Medicinal finished product batches produced worldwide and used in clinical trials sponsored by J&J batch confirmation/release of IMP produced and/or stored at Janssen Pharmaceutica NV in Beerse, Geel, Merksem and La Louvière Principal Duties Acting as Qualified Person (QP) as per legislation for GMP Manufacturing and Importation Authorization (MIA) IMP of Janssen Research & Development, a division of Janssen Pharmaceutica NV Serving as the Global Quality Point of Contact for IMP QP related topics on Small and Large molecule compounds as well as Vaccines Leading and mentoring the IMP QP team including teams responsible for Quality management, Regulatory Compliance Check, QP certification, Post QP certification and Early Development Product Quality Integrators/QPs. Ensuring QP oversight for the Clinical Phase 1 Unit (CPU) at Merksem Serving as the Single Point of Contact for global Quality departments such as BRQC, PQM, CQ, EQ as well as global business partners such as PDMS, VPAD, GCO and CPU Merksem. Establishing and developing strong working relationships with those departments, including single quality voice regarding IMP QP related topics Serving as champion for IMP QP requirements during development of new products, including fit-for-purpose strategy on GMP requirements. Applies Quality Risk Management tools in support of smart development. Ensuring Quality and Compliance operational targets are met Reviewing and approving related GMP documents such as procedures and work instructions, investigations, etc Leading and acting as spokesperson during Health Authority inspections and customer audits Ensuring current in knowledge, skills and industry trends With focus on Quality activities, developing and fostering an environment of innovative thinking through e.g. benchmarking, training, participating in industry forums Reporting Quality trends and makes a positive contribution by making suggestions for improvement. Ensures defined Quality and Compliance improvements are implemented globally Qualifications Job Qualifications: University degree, scientific orientation (pharmaceutical, chemical or biological sciences). Qualified Person is a must. 10- 15 years’ experience in pharmaceutical industry Ability to provide strategic leadership to meet business objectives and a highly dynamic business environment Production related expertise required Experience in product development Ability to quickly assimilate new technologies, perform risk assessment and develop action plans In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards, and procedures Experience with Quality Systems Experience with regulatory inspections and preparedness People management skills, experienced team leader Demonstrated ability to work across organizational boundaries through influencing, negotiation and partnering. Negotiation, communication, and presentation skills across all levels are important Understands the business implications regarding quality positions and decisions Primary Location Belgium-Antwerp-Beerse- Organization Janssen Pharmaceutica N.V. (7555) Job Function Quality Requisition ID 2206046157W