Global Healthcare Compliance Leader — Biotech Launch

uniQure; Lexington (MA); Hybrid; USD 309,000 - 399,000; Full time

Job summary

uniQure, a pioneer in gene therapy, is seeking a VP, Healthcare Compliance to architect and run the global healthcare compliance program as the company readies its first commercial product in the United States. You will partner with commercial, medical, and market access teams to align policy, training, and monitoring with regulatory requirements.

This hybrid Lexington, MA role requires 15+ years in compliance, a regulatory mindset, and the ability to operate in a small biotech environment.

Qualifications

• BA/BS required; JD/advanced degree a plus
• 15+ years in global biopharma compliance roles
• Experience building a compliance program for initial commercial launch
• Strong ability to manage multiple tasks in fast-paced environment

Responsibilities

• Design and operationalize uniQure's global healthcare compliance program
• Lead policy development, training, risk assessment and reporting
• Promote a culture of ethics across the organization during launch
• Monitor and audit compliance systems; field monitoring post-launch
• Collaborate with commercial, medical and market access teams
• Investigate and resolve complex ethics and compliance matters

Skills

Leadership

Communication

Regulatory knowledge

Cross-functional collaboration

Travel ready

Independence

Interpersonal skills

EU/EFPIA familiarity

Professionalism & ethics

Verbal & written skills

Education

BA/BS degree

J.D. or advanced degree

15+ years global compliance experience

Job description

uniQure, a pioneer in gene therapy, is seeking a VP, Healthcare Compliance to architect and run the global healthcare compliance program as the company readies its first commercial product in the United States. You will partner with commercial, medical, and market access teams to align policy, training, and monitoring with regulatory requirements.

This hybrid Lexington, MA role requires 15+ years in compliance, a regulatory mindset, and the ability to operate in a small biotech environment.