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About the Role

The Clinical Quality and Compliance Lead is a key role within Clinical Development Operations, responsible for ensuring ongoing compliance with Quality Standards, Standard Operating Procedures, and Health Authority/Country Regulations for all Ipsen Clinical Trials. This role partners closely with Head Site Management and Monitoring and TA Leads to maintain compliance and contribute to building a quality plan that aligns with global priorities. The ideal candidate is a strong communicator, leader, team player, quick learner, and problem-solver, capable of working independently.

Responsibilities

Contribute to building a Cluster quality plan aligned with Global Quality priorities.
Ensure clinical trials are delivered to the highest quality standards and follow all applicable SOPs, laws, and regulations.
Ensure the CDO team is adequately trained and onboarded.
Collaborate with Cluster Head, Clinical Project Managers, and study teams to ensure inspection readiness.
Develop and monitor effective implementation of CAPAs resulting from regulatory inspections.
Contribute to building a long-term quality plan for the cluster(s) ensuring high-quality delivery of investigator sites and IPSEN/FSP staff.
Proactively measure and identify compliance risks and define remediation actions.
Supervise progress and confirm effectiveness of remediation plans and conduct QC checks on trials and processes.
Support Clinical Operations roles with quality issues for the Quality/Risk Management System.
Liaise with investigation owner and CAPA Manager to identify appropriate CAPA owner.
Act as a liaison between the record owner and quality leader, Root Cause Analysis group, and CAPA Manager.
Assist Investigation Owner and CAPA Manager in applying structured problem-solving methodologies in RCA investigations.
Support Clinical Operations issue owner on logistical aspects of issue resolution.
Identify additional stakeholders if needed to support RCA investigations and resulting actions.
Support discussions with stakeholders.
Keep oversight on CAPA milestones with CAPA Manager.
Timely escalate systemic issues to Head Site Management and Monitoring and Global Quality/QA roles.
Track quality issues with respect to timelines and affected areas/topics.
Monitor audit and inspection announcements for timely involvement of Medical and Clinical Operations SMEs.
Support Global QA, Head of Site Management and Monitoring, and/or TA Heads with document or data requests during audits and inspections.
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 align with Global Quality plans and risk assessments.
Support CDO Leaders to identify appropriate SMEs 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.
Perform impact assessments of new/revised local regulations and provide guidance.
Keep local regulatory intelligence up to date.
Perform local supplier assessments.
Coordinate annual due diligence update, certification, and training of local suppliers.
Lead and/or participate in special initiatives related to quality and compliance outcomes.
May assume additional responsibilities such as 'Quality/Compliance Champion', 'Compliance Subject Matter Expert', or 'Business Process Owner'.

Requirements

A minimum of 8 years of previous Pharmaceutical Industry experience is required.
At least 5 years of GXP experience within clinical research and development and/or quality assurance.
Experience in Quality Control and Compliance, Quality Assurance, CAPA process and/or Root Cause Analysis.
Knowledge of the overall drug development process.
Well-developed skills and knowledge of clinical operations business processes and practices (i.e., SOPs governing clinical research activities).
Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset.
Planning and tracking skills.
Ability to see the big picture.
Well organized.
Focused on results.
Customer focused.
Capable of managing multiple projects.
Excellent time management with respect to priorities and self-management.
Ability to motivate professional colleagues and stakeholders.
Proven conflict resolution/management and negotiation skills.
Ability to independently plan, organize, coordinate, manage and execute assigned tasks.
Demonstrated clarity of communication.
Demonstrated ability to influence key internal and external stakeholders.
Experience of the key customers’ business processes and practices.
Demonstrated ability to deliver a culture of continuous improvement.
Demonstrated ability to engage with authorities, trade associations and key sites.
Experience across all Clinical Trial Phases 1-4 would be preferred.
Experience in Oncology would be preferred.
Batchelors Degree in life sciences or a professional degree in life sciences (eg Nursing , Pharmacy).
Project Management Certificate (PMP/PRINCE2 etc.) is preferred.
Fluent in English.
Fluent in the languages for the countries to be supported at country/cluster level is preferred.

Skills

Quality Standards
Standard Operating Procedures
Health Authority/Country Regulations
Clinical Trials
Quality Assurance
CAPA process
Root Cause Analysis
Drug development process
Clinical operations business processes
Audits
Planning
Tracking
Organization
Results-oriented
Customer focus
Project management
Time management
Self-management
Motivation
Conflict resolution
Negotiation
Communication
Influence
Continuous improvement
Regulatory intelligence
Supplier assessment
Due diligence
Certification
Training

Location

Work Type

Full-time

Experience Level

Minimum of 8 years of previous Pharmaceutical Industry experience
At least 5 years of GXP experience within clinical research and development and/or quality assurance

Education Level

Bachelors Degree in life sciences or a professional degree in life sciences (e.g. Nursing, Pharmacy)
Project Management Certificate (PMP/PRINCE2 etc.) preferred

About the Company

Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease, and Neuroscience.
Supported by nearly 100 years of development experience, with global hubs in the U.S., France, and the U.K.
Tackles areas of high unmet medical need through research and innovation.
Passionate teams in over 40 countries work to bring medicines to patients in 88 countries.
Fosters a workplace that champions human-centric leadership and a culture of collaboration, excellence, and impact.
Empowers individuals to be their true selves, grow, and thrive alongside the company’s success.
Aims for sustainable growth, creating real impact on patients and society.

Equal Opportunity

Committed to creating a workplace where everyone feels heard, valued, and supported.
Embraces diversity and values different perspectives and experiences.
Drives commitment to inclusion and equal opportunities.
Believes diverse ways of thinking lead to more thoughtful decisions and innovative solutions.
Strives to better understand the communities served.
Offers support during the application process for any required adjustments or assistance.