Senior Clinical Quality & Compliance Lead

Ipsen Biopharmaceuticals Inc.; Cambridge (MA); On-site; USD 135,000 - 165,000; Full time

Benefits offered by this job

401(k) with company contributions

Medical coverage

Dental coverage

Paid time off

Job summary

Ipsen is seeking a Clinical Quality and Compliance Lead within Clinical Development Operations to ensure ongoing compliance with Quality Standards, SOPs, and Health Authority regulations across Ipsen clinical trials.

You will partner with Head Site Management and Monitoring, TA Leads, and the CAPA team to build cluster quality plans, monitor CAPA timelines, and drive root cause analyses and inspection readiness.

Qualifications

• Minimum 8 years in Pharmaceutical Industry with at least 5 years in GXP within clinical research/QA
• Experience in Quality Control and Compliance, CAPA, and RCA processes
• Well-developed knowledge of clinical operations and SOPs governing clinical research activities

Responsibilities

• Contribute to building a long-term cluster quality plan ensuring high-quality delivery and proactive remediation actions
• Liaise with CAPA Manager to identify appropriate CAPA owners and assist RCA investigations
• Support issue owners on CAPA milestones and ensure timely escalation of systemic issues
• Monitor audit/inspection readiness and assist with data requests during inspections

Skills

Quality Assurance

CAPA process

Root Cause Analysis

Audits

Regulatory knowledge

Clinical operations

Stakeholder management

Education

Batchelors Degree in life sciences

Job description

Ipsen is seeking a Clinical Quality and Compliance Lead within Clinical Development Operations to ensure ongoing compliance with Quality Standards, SOPs, and Health Authority regulations across Ipsen clinical trials.

You will partner with Head Site Management and Monitoring, TA Leads, and the CAPA team to build cluster quality plans, monitor CAPA timelines, and drive root cause analyses and inspection readiness.