Position Title: Sr. Specialist, Process & Personnel Qualification Management Expert Join Johnson & Johnson's R&D Quality Team! Are you passionate about ensuring compliance and driving quality excellence in the pharmaceutical and healthcare industry? As a Sr. Specialist in Process & Personnel Qualification Management, you will play a pivotal role in shaping the future of research and development at Johnson & Johnson. In this role, you will be at the forefront of quality and compliance oversight, working closely with teams across multiple therapeutic areas. This is an exceptional opportunity for an individual who thrives in a collaborative environment and is eager to make a real difference in the healthcare space. What You'll Do: + Lead Process Design and Implementation: You will be responsible for mapping, analyzing, developing, and implementing compliant and efficient end-to-end processes within our GxP Quality Management Framework. Your expertise will ensure that our processes are not only efficient but also align with the highest regulatory standards, enabling our business partners to conduct R&D seamlessly and confidently. + Champion Quality Across Teams: As a representative of R&D Quality and the Process and Data Management team, you will serve as a key partner to preclinical, Medical Safety, and therapeutic area teams. You will foster collaboration and act as a conduit between business partners, quality groups, and governance, ensuring that our GxP Quality Framework adapts proactively to business and regulatory changes. + Transform Quality Management: You'll spearhead the implementation of our transformation roadmap, driving our evolution towards data-centric content and a robust qualification management system. Your focus will be on enhancing the internal first-time-right processes, from initial requests to the effective delivery of training and qualification materials. + Project Management Excellence: You will support complex project management across all lifecycle phases, from process design to implementation. Your ability to lead tasks, timelines, and deliverables will be crucial for achieving successful project outcomes. You will also help address issues and handle risks, providing timely updates to management and business owners on project progress. + Continuous Improvement Initiatives: Your role includes seeking continuous improvement of our internal delivery, employing standard processes and systems to maximize operational efficiency. By analyzing business processes and identifying areas of enhancement, you will drive the delivery of high-quality outcomes. **Qualifications** Qualifications and Required Knowledge: + Education: A Bachelor’s degree in Science or Business is required. + Experience: A minimum of 3-5 years' experience in a medium to large-scale matrix organization, including at least 3 years in a pharmaceutical/device compliance-related field. Experience in process design and training design is also crucial. + Communication Skills: Excellent oral and written communication skills in English, with the ability to convey sophisticated ideas clearly and effectively. + Regulatory Knowledge: Strong understanding of worldwide (pre)clinical safety compliance regulations and guidelines, as well as exposure to the regulatory landscape within the life sciences industry. + Project Management Skills: Proven ability to manage complex projects and facilitate collaboration across multiple teams and departments. + Analytical Skills: High attention to detail and strong analytical thinking capabilities to assess business processes and drive improvements. + Leadership and Networking: Proven personal leadership, relationship-building skills, and the ability to nurture an inviting work environment that embraces diversity. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.