Senior Manager, Clinical Quality

Scorpion Therapeutics; Philadelphia (Philadelphia County); On-site; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics in the United States seeks a Senior Manager, Clinical Quality to oversee clinical trial quality across phases I–IV, ensuring rigorous adherence to GCP and global regulations.

You will lead quality systems, support regulatory inspections, conduct risk assessments, and mentor cross-functional teams. This role includes about 10-15% travel and requires extensive QA experience in regulated environments.

Qualifications

• Extensive experience in GCP quality assurance within clinical development.
• Strong understanding of global regulations (ICH GCP, FDA, EMA, MHRA, Health Canada).
• Proven track record leading audits and investigations.
• Vendor oversight in regulated environments.

Responsibilities

• Provide proactive QA for global Phase I–IV studies.
• Review study documents and identify Critical-to-Quality factors.
• Lead investigations into deviations and noncompliance.
• Conduct site and vendor audits and evaluate findings.
• Support inspection readiness and regulatory inspections.
• Develop and improve quality systems and processes.
• Perform trend analysis for continuous improvement.

Skills

GCP quality assurance

Audits & investigations

Vendor oversight

Regulatory inspections

Job description

Role:

Senior Manager, Clinical Quality at a biotech developing therapies for rare diseases, focusing on clinical trial quality oversight.

Responsibilities:

provide proactive QA for global Phase I-IV studies, review study documents, identify Critical-to-Quality factors, lead investigations into deviations and noncompliance, conduct audits of sites and vendors, evaluate findings, and support inspection readiness. Develop and improve quality systems and processes, support regulatory inspections, and perform trend analysis for continuous improvement.

Requirements:

extensive experience in GCP quality assurance within clinical development, with a strong understanding of global regulations (ICH GCP, FDA, EMA, MHRA, Health Canada). Proven track record leading audits, investigations, and vendor oversight in a regulated environment.

Preferred:

experience supporting clinical trials in rare diseases, especially with cell-penetrating peptide technologies, and familiarity with clinical trial lifecycle management.

High-value:

oversight of Phase I-IV studies, global scope, cross-functional partnership, vendor and site audits, regulatory inspection support.

WorkSetup:

approximately 10-15% travel.