Senior Director, Clinical Quality

Scorpion Therapeutics; United States; Remote; USD 180,000 - 280,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Director of Quality Assurance to oversee clinical quality across development stages, emphasizing GCP and GPvP compliance. The role leads QA strategy and regulatory readiness.

You will manage audits of CROs and vendors, review clinical/regulatory documents, and foster a quality-centric culture while travelling ~25% and supporting international sites as needed. Remote USA work setup.

Qualifications

• Bachelor's degree in a scientific or related field.
• 12+ years in pharma/biotech.
• Extensive GCP/GPvP knowledge.
• Experience with audits, inspections, and regulatory submissions.

Responsibilities

• Develop risk-based QA strategies.
• Oversee audits of CROs and vendors.
• Manage compliance risks.
• Lead regulatory inspections.
• Review clinical and regulatory documents.
• Foster a quality-centric culture.

Skills

GCP/GPvP knowledge

Leadership

Auditing & inspections

Regulatory submissions

Education

Bachelor's degree in science or related field

12+ years pharma/biotech experience

Tools

Veeva

SharePoint

Job description

Role: Senior Director of Quality Assurance overseeing clinical quality in biopharma, focusing on GCP and GPvP compliance across clinical development stages.

Responsibilities

• develop risk-based QA strategies
• oversee audits of CROs and vendors
• manage compliance risks
• lead regulatory inspections
• review clinical and regulatory documents
• foster a quality-centric culture

Requirements

• Bachelor's in a scientific or related field with 12+ years in pharma/biotech
• extensive GCP/GPvP knowledge
• experience with audits, inspections, and regulatory submissions
• demonstrated leadership in clinical QA

Preferred

• oncology experience
• support for mid-to-late-phase trials
• familiarity with Veeva and SharePoint
• ability to travel ~25%

HighValue

• clinical-stage biotech
• oncology focus
• GCP, GPvP
• GLP support
• regulatory inspection readiness
• vendor oversight
• clinical documentation review
• international travel

Work Setup

remote USA.