Director, Systems and Quality - Job ID: DSQT

DescriptionAscendis 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 ResponsibilitiesMaintains 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 appropriateAnalyzes 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 programServes as a Super User for Veeva and illuminate on the Clinical Development teamActs as TMF Ambassador for Clinical DevelopmentLiaises with IT as appropriate on behalf of Clinical DevelopmentServes 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 strategyPromotes quality-by-design from study conception and protocol design, study start-up, trial conduct, through reporting on study resultsPromotes a quality culture and coordinates inspection readiness activities (including maintaining the eTMF and other documentation) throughout the clinical trial processPartners with SMEs to mitigate identified risksCollaborates with subject matter experts and senior management to formulate responses to audit and inspection findingsCoordinates and supports preparation, review, and finalization of deviations, investigations, root cause analyses, corrective/preventative actions, and change controlsCatalogues, tracks, reviews, and analyzes audit, inspection, and quality event data to identify trends and areas of exposureActs 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 DevelopmentProvides guidance on interpretation and application of specified regulations to Clinical DevelopmentOptimizes 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 trainingPartners to direct training on SOPs to ensure compliance with regulatory requirementsArranges appropriate event-related training, e.g., for audits & inspections, system training for newly implemented/upgraded systemsActs as Cornerstone Learning Administrator for Clinical DevelopmentEnsures appropriate and adequate training documentationRequirementsBachelors degree required. Advanced clinical/science degree preferred (e.g., PhD, PharmD, MSN, MPH)10+ years of industry experience in related roleExperience in global GCP regulations and quality systems management, establishing and tracking metrics, compliance monitoring, and the development and maintenance of SOPs and training programsExperience in regulatory inspections (preparation and follow up)Analysis and decision-making based on sound risk-based judgmentAbility to handle multiple projects simultaneously and to prioritize tasks in a dynamic environmentAbility to speak effectively and communicate directly with cross-functional colleagues in a positive/constructive and collaborative mannerPossesses excellent communication skills, both verbal and written, and ability to write clearly and conciselyStrong self-motivation, ability to work independently as well as in a team environmentProficient knowledge of Veeva and Cornerstone is desirableAbility and willingness to travel approximately 10-15% of the time, domestically and internationally The estimated salary range for this position is $210-225K/year. Actual salary determination is dependent on a variety of factors, some of which include: experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.Benefits401(k) plan with company matchMedical, dental, and vision plansCompany-offered Life and Accidental Death & Dismemberment (AD&D) insuranceCompany-provided short and long-term disability benefitsUnique offerings of Pet Insurance and Legal InsuranceEmployee Assistance ProgramEmployee DiscountsProfessional DevelopmentHealth Saving Account (HSA)Flexible Spending AccountsVarious incentive compensation plansAccident, Critical Illness, and Hospital Indemnity Insurance Mental Health resourcesPaid leave benefits for new parentsAscendis Pharma is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees.A note to recruiters:We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.Job SummaryID: 764BEB7DC3Department: Clinical Development, Endocrine, Clinical Development Endocrinology