Senior Director, Clinical Quality & Development Ops (Biotech)

TL;DR

Senior Director, Clinical Quality & Development Ops (Biotech): Providing enterprise-level leadership and strategic oversight to ensure Global Clinical Operations maintains a sustained state of GCP compliance. Focus on proactive risk identification, regulatory compliance, and effective quality risk mitigation across the clinical development portfolio.

Location: Remote-eligible (US-based), with options for Remote, Hybrid, or On-Site work in Boston, MA.

Salary: $222,200 – $333,200

Company

A global biotechnology company dedicated to scientific innovation and the development of transformative medicines.

What you will do

• Lead Quality Event Management, including investigations, root cause analysis, and CAPA plan development for Global Clinical Operations.
• Oversee the development and implementation of Risk Management Plans (RMPs), site hold/closure activities, and quality risk assessments.
• Drive inspection readiness programs and develop lessons learned to ensure continuous process improvement.
• Harmonize global processes and operational standards across clinical programs to ensure regulatory compliance.
• Provide strategic leadership to cross-functional teams and represent Clinical Quality & Development Operations on large-scale initiatives.
• Manage financial and human resource responsibilities for assigned staff.

Requirements

• Bachelor of Science degree in a life sciences discipline.
• Typically requires 15 years of experience in the biopharmaceutical industry.
• Minimum 5 years of supervisor or management experience.
• Expert understanding of GCP, CFR, and ICH guidelines and Health Authority regulations.
• Extensive experience in Global Clinical Operations and Clinical Development across multiple therapeutic areas.
• Must be authorized to work in the United States.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance coverage.
• Generous paid time off, including company-wide shutdowns in Summer and Winter.
• Educational assistance programs, including student loan repayment.
• 401(k) retirement plan with company matching.
• Flexible work arrangements including remote, hybrid, and on-site options.
• Supportive environment focused on professional growth and wellbeing.