Manager, QA Operations

Part of Global Quality organization and Partner of the Research & Development and Global Medical Affairs (including interfaces) you are a key contributor of the clinical & Medical QA organization, you are accountable for ensuring a compliant state of the clinical studies/programs managed by IPSEN R&D and Global Medical Affairs across Therapeutic Areas; as well as ensuring clinical and medical quality activities are effective, executed and maintained in compliance with the applicable regulations and Ipsen standards.

You will act as the Quality point of contact/key partner for clinical teams for the studies assigned including interface functions. In this position, you will also conduct Quality-related activities for the clinical studies assigned, ensure consistency and standardization in operational methodology and processes. Additionally, this position supports related integration process in the Therapeutic Area.

• For the clinical studies/programs assigned, works with the clinical and medical teams to ensure good clinical practices and relevant regulatory requirements are met.
• Ensure quality oversight of the clinical studies and programs within their remit and ensure consistency and standardization in operational methodology and processes in their management.
• Act as a key partner for to cross functional study teams, to provide quality assurance expertise and guidance
• Monitor quality performance of the clinical studies/programs: data collection, targets definition, best practices promotion, improvement initiatives, and appropriate reporting.
• Escalate systemic problems and appropriate recommendations/solutions to management for immediate and long-term resolution
• Reviews contracts with clinical vendors and partners to ensure compliance responsibilities are included
• Other assignments as directed by QA management (e.g.: New projects)
• Support the preparation of the clinical quality plan including analysis
• Ensure quality of the clinical studies/programs initiated by the local (affiliate) as per a risk-based approach
• Ensure timely assistance for quality related topics.
• Support Service Provider QA Operations in the quality oversight of SP activities.
• Escalate to Manager identified issues that need to be discussed during the oversight and/or steering committee

• Contribute to integration process in collaboration with CM Quality System
• Provide clinical quality related input to business functions

• Support and facilitates implementation and continuous improvement for clinical quality and operational processes.
• Ensure proper management including documentation, investigation, and CAPA definition of major/critical Quality Events and potential Serious Breaches in GCP.
• Monitor the clinical regulatory environment to ensure the continued compliance of the quality system and subsequent implementation plans.
• Contribute to development of plans for quality documentation related activities.
• Contribute to training sessions as SME, by reviewing training materials or participating in presentations.
• Perform Risk Assessment and ensures communication to management and documentation in eQMS.
• Foster a culture of continuous process improvement by monitoring CAPA effectiveness and facilitating Quality Risk Management activities.
• Report CAPA status and metrics, escalating any issues regarding delayed timelines or ineffectiveness of CAPA, as needed.
• Ensure timely delivery by following up with CAPA owners and scheduling meetings as necessary.

• Quality Assessments
• Contribute to preparation of the quality assessment plan through the identification of sub-optimal processes.
• Quality assessment execution: prepare agenda, interviews, opening, closing, reporting and CAPA follow-up.

• Contribute to inspection readiness activities
• Contribute to GCP inspections and ensure smooth organization of the front office and back office
• Provide responses and address questions and observations during inspection when observations are related to the role or responsibilities of the QA function
• Follow-up implementation of CAPAs and ensure timely completion

• Support the audit activities by providing necessary study information to global audit group for risk assessment and audit plan
• Collaborate with R&D and GMA in the risk-based oversight of clinical service providers
• Assist in resolving compliance issues at clinical sites, clinical SP, laboratories and other SP by providing an assessment of the impact of any deficiencies and follow-up of CAPA implementation and ensure timely completeness
• Support global internal audits and implement CAPAs to address the issues raises

• Develop and communicate Corporate Quality Objectives applicable to clinical research.
• Serve as liaison between the Global Quality System department and functional entities involved in clinical research.
• Share major deviations and serious breaches…