Director, Systems and Quality

Ascendis Pharma

. Maintain an overview of systems and processes relevant to Clinical Development and their interfaces .

Posted 9/15/2026full-timePrinceton • New Jersey • United StatesLead💰 $210,000 - $225,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Development processes, regulatory compliance, and quality systems management, with a strong focus on GCP regulations and risk management. Proficient in coordinating training programs and maintaining documentation to ensure inspection readiness and continuous improvement.

Highest-signal resume keywords

Clinical Development ExpertiseGCP Regulations KnowledgeSOP Development and ManagementRisk Management and MitigationVeeva Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Systems ManagementRegulatory Inspections PreparationMetrics Establishment and TrackingDocument ManagementRisk-Based Decision Making

Soft Skills

Effective CommunicationCollaborationSelf-MotivationProject ManagementProblem Solving

Tools & Technologies

VeevaCornerstone LearningETMF

Industry Keywords

Clinical TrialsGxP Best PracticesSOP TrainingAudit and Inspection FindingsContinuous Improvement

About the role

Key responsibilities & impact

Maintain an overview of systems and processes relevant to Clinical Development and their interfaces
Monitor systems and processes to identify SOP changes, coordinate document updates, and initiate new documents
Analyze and refine system and process interfaces across the molecule lifecycle
Promote consistency and efficiency across teams and programs
Serve as Clinical Development Super User for Veeva and illuminate
Act as TMF Ambassador for Clinical Development
Liaise with IT on behalf of Clinical Development
Provide expert advice on identifying, managing, and mitigating risks in clinical trials and development strategy
Promote quality-by-design from study conception through reporting of study results
Coordinate inspection-readiness activities and maintain the eTMF and other documentation
Partner with SMEs to mitigate risks and formulate responses to audit and inspection findings
Coordinate deviations, investigations, root cause analyses, corrective/preventive actions, and change controls
Track, review, and analyze audit, inspection, and quality-event data to identify trends and exposure areas
Act as Clinical Development SME on Monitoring of External Requirements (MER)
Monitor GCP, industry trends, practices, and regulatory guidelines and assess their impact
Drive cross-functional GxP best practices and continuous improvement
Provide guidance on interpreting and applying regulations to Clinical Development
Optimize training based on team roles and timing
Maintain feedback loops between outcomes, processes, systems, and training
Direct SOP training and arrange event-related and system training
Act as Cornerstone Learning Administrator for Clinical Development
Ensure adequate training documentation

Requirements

What you’ll need

Bachelors degree required
10+ years of industry experience in a related role
Experience in global GCP regulations and quality systems management
Experience establishing and tracking metrics, compliance monitoring, and developing and maintaining SOPs and training programs
Experience in regulatory inspections, including preparation and follow-up
Analysis and decision-making based on sound risk-based judgment
Ability to handle multiple projects simultaneously and prioritize tasks in a dynamic environment
Ability to communicate effectively and directly with cross-functional colleagues in a positive, constructive, and collaborative manner
Excellent verbal and written communication skills, with the ability to write clearly and concisely
Strong self-motivation and ability to work independently and in a team environment
Ability and willingness to travel approximately 10–15% domestically and internationally
Advanced clinical/science degree (e.g., PhD, PharmD, MSN, MPH) preferred
Proficient knowledge of Veeva and Cornerstone desirable

Benefits

Comp & perks

401(k) plan with company match
Medical, dental, and vision plans
Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
Company-provided short and long-term disability benefits
Pet Insurance and Legal Insurance
Employee Assistance Program
Employee Discounts
Professional Development
Health Saving Account (HSA)
Flexible Spending Accounts
Various incentive compensation plans
Accident, Critical Illness, and Hospital Indemnity Insurance
Mental Health resources
Paid leave benefits for new parents
Discretionary annual bonus or incentive compensation plan eligibility
Discretionary stock-based long-term incentives
Paid time off
Comprehensive benefits package