Systems & Quality Director, Clinical Development

Ascendis Pharma A/S; Princeton (NJ); On-site; USD 210,000 - 225,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, dental, and vision plans

Life and AD&D insurance

Disability benefits

Pet Insurance

Job summary

Ascendis Pharma A/S is seeking a Director of Systems, Quality, and Training to support the Clinical Development team. Lead management of systems, SOPs, and training to ensure compliant, fit-for-purpose processes across the product lifecycle.

You will drive risk-based quality improvements, oversee TMF activities, and collaborate with SMEs and senior leadership to ensure inspection readiness and continuous improvement.

Qualifications

• Bachelor’s degree required; advanced clinical degree preferred.
• 10+ years of industry experience in quality/regulatory roles.
• Experience with GxP, SOPs, training programs, and risk-based quality management.
• Experience in regulatory inspections and metrics development.
• Ability to manage multiple projects and communicate effectively.

Responsibilities

• Maintain systems and processes overview for Clinical Development.
• Promote quality by design and manage risk in trials.
• Serve as Super User for Veeva and Cornerstone; act as TMF Ambassador.
• Collaborate with IT and cross-functional teams to drive process improvements.

Skills

Leadership

Regulatory knowledge

Risk management

Quality systems

Project management

Education

Bachelor's degree

Advanced clinical/science degree (PhD/PharmD/MSN/MPH)

Tools

Veeva

Cornerstone

Job description

Ascendis Pharma A/S is seeking a Director of Systems, Quality, and Training to support the Clinical Development team. Lead management of systems, SOPs, and training to ensure compliant, fit-for-purpose processes across the product lifecycle.

You will drive risk-based quality improvements, oversee TMF activities, and collaborate with SMEs and senior leadership to ensure inspection readiness and continuous improvement.