Clinical Quality and Compliance Lead

Ipsen Biopharmaceuticals Inc.

The Clinical Quality and Compliance Lead is a key role in the Clinical Development Operations function responsible to ensure ongoing compliance to appropriate Quality Standards, Standard Operating Procedures, Health Authority/Country Regulations and guidelines for all Ipsen Clinical Trials. He/she will ensure compliance in strong partnership with Head Site Management and Monitoring and TA Leads. The Clinical Quality and Compliance Lead should be able to work independently and be a strong communicator, leader and team player, with demonstrated ability as a quick learner and problem-solver.

This role will

• Partner with Head Site Management and Monitoring and TA Leads to ensure ongoing compliance to appropriate Quality Standards, Standard Operating Procedures, Health Authority/Country Regulations and guidelines. The Clinical Quality and Compliance Lead  should be able to work independently and be a  strong communicator, leader and team player, with demonstrated ability as a quick learner and problem-solver
• contribute in building a Cluster quality plan  that aligns the Global Quality priorities and initiatives and that will ensure IPSEN  clinical trials are delivered to the highest quality standards and are following all applicable SOP's, laws and regulations.
• ensure the CDO team is adequately trained and onboarded. Our new colleague should be flexible and able to work independently.
• collaborate with the Cluster Head, the Clinical Project Managers and the wider study teams, carrying out the clinical trials, across both internal IPSEN/FSP to assure inspection readiness at all times and to be responsive in developing and monitoring effective  implementation of CAPAs as a result of regulatory inspection
•  be part of a hardworking, enthusiastic, and committed team eager to deliver and helping to improve the lives of millions of patients.

• Monitor audit and inspection announcements to ensure timely involvement of Medical and Clinical Operations SMEs in support of audit and inspection readiness
• Support  Global QA , Head of Site Management and Monitoring  and/or TA Heads with document or data requests during internal audits and inspections by engaging appropriate SMEs across R&D
• Support Global QA , Head of Site Management and Monitoring  and/or TA Heads and/or responsible issue owner after audit and inspection on CAPA activities

• Work closely with Global Quality to ensure Cluster Quality plans are aligned with Global Quality plans and risk assessments (study and site level)
• Support CDO Leaders to identify appropriate SME to represent CDO for procedural document review/creation
• Track ongoing procedural document review/creation activities for timely involvement and completion
• Work with CDO leaders and cross-functional BPOs on relevant procedural document updates related to CAPA commitments
• Be accountable for continuous improvement of CDO processes

Other

• Local regulatory intelligence: perform impact assessments of new/revised local regulations and provide clear and timely guidance to the teams. Keep local intelligence up to date.
• Collaboration with business quality: perform local supplier assessments; coordinate annual due diligence update, certification and training of local suppliers.

• As required, Leads and/or participates in special (cluster and/or global) initiatives as they relate to quality and compliance outcomes

May assume additional responsibilities or special initiatives such as ' Quality/Compliance Champion', ''Compliance Subject Matter Expert' or 'Business Process Owner'.

• Fluent in English