Regional Compliance Director, Clinical Quality

Ipsen ADR

Cambridge (MA)

On-site

USD 150,000 - 210,000

Full time

3 days ago

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Benefits offered by this job

401(k) plan

Job summary

Ipsen Biopharmaceuticals Inc. seeks an Associate Director, Regional Compliance to lead quality and regulatory compliance for Ipsen Clinical Trials.

The role partners with Head Site Management, Monitoring and TA Leads to ensure adherence to Quality Standards, SOPs, and Health Authority regulations across clinical operations. The incumbent will build cluster quality plans, supervise CAPA and RCA activities, and drive training and onboarding to ensure inspection readiness and continuous process

Qualifications

Experience in quality assurance activities in clinical development or related field.
Knowledge of regulations and guidelines governing clinical research and validation of processes.
Strong communication and cross-functional collaboration skills.

Responsibilities

Ensure ongoing compliance to Quality Standards, SOPs, and regulatory requirements for Ipsen Clinical Trials.
Lead and collaborate with QA and Clinical Operations to inspect readiness and CAPA implementation.
Develop and maintain cluster quality plans aligned with global priorities.
Train and onboard CDO team members; drive continuous improvement of CDO processes.
Coordinate with stakeholders to manage quality issues and remediation actions.