Clinical Quality and Compliance Lead
Ipsen
Summary
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.
Job description
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.
Main Responsibilities
Compliance Support
- Contribute in building a long-term quality plan for the cluster(s), one that ensures high quality delivery of investigator sites and of IPSEN and FSP staff
- Proactively measure and identify compliance risks and define remediation actions to manage those risks (study and site level)
- Supervise progress and confirm effectiveness of remediation plans and conduct QC checks on trials and processes
- Support Clinical Operations roles with quality issues that need to be captured in Quality /Risk Management System
- Liaise with investigation owner and CAPA Manager to identify appropriate CAPA owner (study specific vs. general/systemic issue)
- Act as a liaison between the record owner and the quality leader; the record owner and the Root Cause Analysis group; the record owner and the CAPA Manager
- Assist the Investigation Owner and CAPA Manager in the application of structured problem-solving methodologies in Root Cause Analysis (RCA) investigations
- Support Clinical Operations issue owner on logistical aspects of issue resolution
- Keep oversight on CAPA milestones together with CAPA Manager
- Timely escalate systemic issues identified during issue discussion to Head Site Management and Monitoring and to Global Quality/QA roles
- Track quality issues with respect to timelines and affected areas/topics
Audit & Inspection Support (Study and Site)
- 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
Process Governance Support
- 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'
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, able 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
- Bachelors Degree in life sciences or a professional degree in life sciences (eg Nursing, Pharmacy)
- Project Management Certificate (PMP/PRINCE2 etc.)
- Fluent in English
- Fluent in the languages for the countries to be supported at country/cluster level
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Life Insurance
- Disability Insurance
- Flexible Spending Accounts
- Parental Leave
- Paid Time Off
- Winter Shutdown
- Well-being Allowance
- Commuter Benefits
Company overview
Ipsen is a French biopharmaceutical company headquartered in Paris, France, with a global presence in over 40 countries. Founded in 1929 by Henri Beaufour, the company has evolved into a leading mid-size pharmaceutical firm specializing in three key therapeutic areas: oncology, rare diseases, and neuroscience. With approximately 5,300 employees worldwide, Ipsen operates as a publicly traded company on Euronext Paris while maintaining significant family ownership through the Beaufour family. The company's portfolio includes innovative treatments such as Cabometyx for advanced cancers, Dysport for neurological conditions, and Bylvay for rare liver diseases. Ipsen has established itself as one of the world's top 15 biopharmaceutical companies in oncology sales, with medicines registered in 88 countries and direct commercial operations in over 30 nations. The company maintains four global R&D hubs and three pharmaceutical development centers, investing significantly in research and development to advance transformative medicines for patients with limited treatment options.