Clinical Quality & Compliance Leader

Ipsen; Cambridge (MA); Hybrid; USD 135,000 - 165,000; Full time

Benefits offered by this job

401(k) plan

Comprehensive medical/dental/vision

Life and disability insurance

Flexible spending accounts

Parental leave

Paid time off

Well-being allowance

Commuter benefits

Job summary

Ipsen Biopharmaceuticals Inc. seeks a Clinical Quality and Compliance Lead to ensure ongoing adherence to quality standards, SOPs and regulatory guidelines across Ipsen clinical trials.

You will partner with site management leads and project teams to drive inspection readiness and CAPA execution while advancing a cluster quality plan aligned with global priorities. With 8+ years in pharma and strong QA/RCA/CAPA experience, you will influence cross-functional teams, manage risk, oversee audits,

Qualifications

• Minimum 8 years in the pharmaceutical industry with at least 5 years in clinical development quality and compliance.
• Experience in CAPA, RCA, QA activities and audits of sites and vendors.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Develop cluster quality plans aligned with Global Quality priorities and local risk assessments.
• Identify and remediate compliance risks; oversee CAPA milestones and track effectiveness.
• Support audits and inspections; prepare documentation and liaise with authorities as needed.
• Lead continuous improvement initiatives within Clinical Development Operations.

Skills

GXP experience

CAPA process

Root Cause Analysis

Quality Assurance

Audit & Inspection

Clinical Operations

Education

Bachelor's Degree in Life Sciences

Job description

Ipsen Biopharmaceuticals Inc. seeks a Clinical Quality and Compliance Lead to ensure ongoing adherence to quality standards, SOPs and regulatory guidelines across Ipsen clinical trials.

You will partner with site management leads and project teams to drive inspection readiness and CAPA execution while advancing a cluster quality plan aligned with global priorities. With 8+ years in pharma and strong QA/RCA/CAPA experience, you will influence cross-functional teams, manage risk, oversee audits,