Director, Systems and Quality - Job ID: DSQT

Ascendis Pharma•Princeton, NJ

9d•Hybrid

About The Position

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.

Requirements

Bachelors degree required.
10+ years of industry experience in related role
Experience in global GCP regulations and quality systems management, establishing and tracking metrics, compliance monitoring, and the development and maintenance of SOPs and training programs
Experience in regulatory inspections (preparation and follow up)
Analysis and decision-making based on sound risk-based judgment
Ability to handle multiple projects simultaneously and to prioritize tasks in a dynamic environment
Ability to speak effectively and communicate directly with cross-functional colleagues in a positive/constructive and collaborative manner
Possesses excellent communication skills, both verbal and written, and ability to write clearly and concisely
Strong self-motivation, ability to work independently as well as in a team environment
Ability and willingness to travel approximately 10-15% of the time, domestically and internationally

Nice To Haves

Advanced clinical/science degree preferred (e.g., PhD, PharmD, MSN, MPH)
Proficient knowledge of Veeva and Cornerstone is desirable

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