Director, Systems and Quality - Job ID: DSQT

About this role

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues. Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.

Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills. The Director of Systems, Quality, and Training supports the Clinical Development team and collaborates closely with our partner functions to ensure robust processes that are compliant, fit-for-purpose, efficient and make sense within the broader framework.

Key Responsibilities Maintains an overview of systems and processes relevant to Clinical Development, and how they interface with each other Continuously monitors existing systems and processes relevant to Clinical Development to determine the need for changes to Standard Operating Procedures (SOPs); coordinates updates to existing documents and initiates new documents as appropriate Analyzes and refines how systems and processes interface with and feed into each other across the lifecycle of a molecule (eg document templates; data collection, review, and delivery; data analysis and reporting; managing vendors) Promotes consistency and efficiency across teams and program Serves as a Super User for Veeva and illuminate on the Clinical Development team Acts as TMF Ambassador for Clinical Development Liaises with IT as appropriate on behalf of Clinical Development Serves as the Clinical Development representative for ensuring quality within our processes and strategies Provides expert advice to identify, manage, and mitigate risk in our clinical trials and our clinical development strategy Promotes quality-by-design from study conception and protocol design, study start-up, trial conduct, through reporting on study results Promotes a quality culture and coordinates inspection readiness activities (including maintaining the eTMF and other documentation) throughout the clinical trial process Partners with SMEs to mitigate identified risks Collaborates with subject matter experts and senior management to formulate responses to audit and inspection findings Coordinates and supports preparation, review, and finalization of deviations, investigations, root cause analyses, corrective/preventative actions, and change controls Catalogues, tracks, reviews, and analyzes audit, inspection, and quality event data to identify trends and areas of exposure Acts as Clinical Development SME on MER (Monitoring of External Requirements) Stays current on GCP, industry trends, practices, and regulatory guidelines and assesses impact to processes and systems relevant to Clinical Development, Partners cross-functionally to determine GxP best practices and drive continuous improvements within processes and systems relevant to Clinical Development Provides guidance on interpretation and application of specified regulations to Clinical Development Optimizes training for Clinical Development based on the team's roles and in terms of timing of trainings Ensures a feedback loop between outcomes and our processes/systems and training Partners to direct training on SOPs to ensure compliance with regulatory requirements Arranges appropriate event-related training, e.g., for audits & inspections, system training for newly implemented/upgraded systems Acts as Cornerstone Learning Administrator for Clinical Development Ensures appropriate and adequate training documentation Requirements Bachelors degree required.