Within Janssen R&D, a member of Johnson & Johnson's Family of Companies, we are recruiting a Senior Quality Assurance Associate to strengthen the post-certification team! Our team is part of the Quality Assurance Clinical Supply Chain team and responsible to guarantee the quality and compliance of our investigational products after they have been certified for use in our clinical trials. We provide QA support for all activities related to our Investigational products at distribution depots, during transport and at the clinical sites: handling of deviations, temperature excursions, product quality complaints and support during audits and inspections by the Health Authorities. 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-CSC team is looking for a Senior QA CSC Associate to join the team and handles E2E the Product Quality Complaints process and the investigations linked to it. As Senior QA-CSC Associate, you will be responsible for Complaint Handling for Clinical Product Quality Complaints and you will act as the subject matter authority. We are seeking a motivated and dynamic individual to join our team! The candidate that we're looking for is someone who is driven, takes initiative, and has demonstrated leadership abilities. Job Description: + Ensure that Complaints are reported, logged and investigated in a timely manner. + Ensure that complaints are properly investigated such that the internal and external customer expectations are met. + Driving the Complaints process to ensure it is evolving as per the needs of the innovative products in the pipeline + Get in touch with all collaborators involved in the investigation (External Quality, Janssen manufacturing sites, Global Clinical Development). + Ensure that adequate CAPA’s are defined for investigations with potential quality impact. + Ensure that quality issues/complaints with potential impact on patients and/or product supply are properly brought up. Gather all info and prepare the escalation meeting to support the Escalation lead. + Support the operational quality performance by leading different quality review meetings. + Take the lead in preparing cross-functional teams for Health Authority inspections. + Act as Subject Matter Expert for the Clinical product Quality Complaint Process. Represent the Quality Voice in Global projects. + Lead/Drive quality in the organisation: Ensure quality is incorporated in the processes & functions + Proactively and continuously challenge the organizational performance and develop and implement improvements in organizational performance. + Establish and maintain effective working relationships with the different business partners to ensure alignment of objectives and deliverables. + Define opportunities for process improvements and develops cases and drives implementation. **Qualifications** Qualifications Job Qualifications: + University degree, scientific orientation (pharmaceutical, chemical, or biological sciences) or equivalent. + Experience in pharmaceutical supply chain and/or Quality Assurance. + Proven track record to work independently while staying connected with key collaborators. + Operational Quality and/or Production related expertise is an asset. + Product development expertise is an asset. + Ability to prioritize, to challenge the steady state and influence + Ability to handle complexity, and to take ownership for deliverables, as well as flexibility and confirmed collaboration skills, are required + Ability to quickly assimilate new technologies and product knowledge, perform risk assessment and develop action plans. + In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures. + Understands the business implications regarding quality positions and decisions + Consistent track record of leadership in previous roles or projects. + Strong problem-solving skills. + Excellent communication and social skills. If you are passionate about inspiring change and making an impact, we encourage you to apply! Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.