Senior Process and Compliance Manager

Role Overview: You will be responsible for ensuring operational excellence related to clinical trial activities within Translational Clinical Oncology (TCO). Your main tasks will include tracking progress to key quality indicators (KQIs), Quality Plan, and overall compliance to applicable processes and regulations. You will lead and assist in the development and implementation of process improvement initiatives within the function and ensure changes are adequately communicated and managed. Collaboration with clinical QA (CQA) and appropriate line functions to uphold high quality standards in TCO will be a key aspect of your role. Key Responsibilities: - Accurate and timely execution of process improvement and quality initiatives to meet key milestones effectively. - Successful implementation of process improvements leading to sustainable changes and improved efficiency. - Increased compliance with relevant processes. - Establishing business partnerships with all relevant TCO functional groups, CQA, training, and other LFs as required. - Implementing training programs in a timely fashion and tracking to ensure compliance and maintenance. Qualifications Required: - A minimum of 5 years of relevant pharmaceutical clinical development experience - Extensive knowledge of clinical development process, GCP, and clinical quality management, including a strong understanding of regulation and guidance for clinical studies - Proficiency/Fluency in English - Experience working in a matrix environment and in global teams - Excellent interpersonal, problem-solving, negotiation, and conflict resolution skills - Excellent organizational skills with a predisposition to quality management and process improvement - Excellent communicator and presenter (oral and written) Additional Details: You will be responsible for tracking, reporting, and reinforcing adherence to applicable performance measures, recommending corrective actions based on report outputs and root cause analysis, and supporting the implementation of training/communication as applicable to ensure remediation (preventative actions). You will support in recommending corrective actions based upon report outputs and root cause analysis, and support implementing training/communication as applicable to ensure remediation (preventative actions). Furthermore, you will be involved in ensuring the timely submission and completion of adequate Corrective Actions Preventative Actions (CAPA), supporting inspection preparation and inspection readiness, and managing audit and inspection outcomes requiring corrective action. Note: The above additional details provide insights into various responsibilities related to tracking, reporting, and ensuring adherence to performance measures, recommending corrective actions, and supporting inspection preparation and readiness.,