Senior Director / Director – GCP Quality

Scorpion Therapeutics; Boston (MA); On-site; USD 180,000 - 250,000; Full time

Job summary

Scorpion Therapeutics in Boston seeks a Senior Director/Director of GCP Quality to oversee clinical GCP and GCLP activities supporting pre-clinical and clinical programs.

You will be the primary GCP quality contact for vendors and investigator sites, lead audits and CAPA, and drive compliance programs, training, and inspection readiness across Boston and Basel teams.

Qualifications

• 16+ years in pharma/biopharma with clinical development and commercial exposure.
• In-depth knowledge of GCP, GxP, and global regulations (FDA, EMA, ICH, MHRA).
• Solution-oriented, adaptable, experienced in fast-paced, matrix environments.
• Hands-on leadership.

Responsibilities

• Serve as primary GCP quality contact for vendors and investigator sites.
• Author and review GCP SOPs and procedures.
• Develop risk-based compliance programs.
• Support investigation and CAPA processes.
• Conduct vendor qualification and audits.
• Provide GCP training for teams.
• Ensure remediation of audit observations.
• Review regulatory submissions and lead inspection readiness.

Skills

GCP Quality Oversight

Vendor Audits

Regulatory Compliance

Leadership

Education

Bachelor's degree in Chemistry/Pharmacy/Biology or related field

Job description

Role

Senior Director / Director of GCP Quality overseeing clinical GCP and GCLP activities supporting pre-clinical and clinical programs.

Responsibilities

act as primary GCP quality contact for vendors and investigator sites, author and review GCP SOPs and procedures, develop risk-based compliance programs, support investigation and CAPA processes, conduct vendor qualification and audits, provide GCP training, ensure audit observation remediation, review regulatory submissions, and lead inspection readiness.

Requirements

BS in Chemistry, Pharmacy, Biology, or related field; 16+ years in pharma/biopharma with clinical development and commercial exposure; in-depth knowledge of GCP, GxP, and global regulations (FDA, EMA, ICH, MHRA); solution-oriented, adaptable, experienced in fast-paced, matrix environments; hands‑on leadership.

High Value

GCP quality oversight, clinical and vendor audits, regulatory inspection preparedness, support for active pre-clinical and clinical programs.

Work Setup

75% on-site in Boston; collaboration with teams in Boston and Basel.