Clinical Quality Assurance Manager
il y a 1 mois
Ipsen is a global biopharmaceutical group dedicated to improving lives and health outcomes through innovative medicines in Oncology, Neuroscience and Rare Disease. We are committed to discovering new treatments in areas with high unmet medical needs and improving the quality of life for patients.
**Research and development are key elements of our strategy, reflecting our commitment to improving patients’ lives and health outcomes.** Bolstered by a culture of collaboration & excellence, Ipsen offers a unique proposition to 5,700+ employees committed to society.
**SUMMARY OF THE POSITION**
- Act as the Primary Point of Contact in Quality for entities or individuals involved with clinical studies.
- Maintain an effective and efficient Quality Systems for the clinical studies to ensure compliance with Ipsen’s quality standards, good working practices and local, national, regional and international legal, ethical and regulatory requirements.
- Ensure timely systematic investigation of the root causes of identified problems or identified risks.
- Ensure timely closure and efficiency of CAPAs by tracking progress, providing summaries and escalating as needed. Participate and oversee GDPR implementation within Ipsen process for clinical activities.
- Contribute to the prevention and escalation of quality risks for clinical studies.
- Supports inspection readiness activities, inspection conduct and post-inspection activities.
**MAIN RESPONSIBILITIES**
**Clinical Study QA representative**:
- For the clinical studies assigned, works with the Clinical Research project manager to ensure good clinical practices and relevant regulatory requirements are met.
- Participates to project meeting and ensure timely assistance for all quality related topics.
- Participates to the vendors’ selection and Quality Assurance Meeting and ensure quality oversight in relation to the studies outsourced.
- Escalate to Manager identified issues that need to be discussed during the oversight and steering committee.
**Maintain a robust Clinical QMS**:
- Support and facilitates implementation and continuous improvement for clinical quality and operational processes.
- Ensures 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 consolidation in the registry.
- 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.
**Compliance activities**:
- **Quality Assessments**:
- Contribute to preparation of the annual quality assessment plan based on sub processes identified.
- Quality assessment execution: prepare agenda, interviews, opening, closing, QA report and recording into eQMS.
- ** Audits and Inspections**:
- Support the audit activities: provide information to audit group for their risk assessment and audit activities, facilitate further investigation of observations (when needed), root cause analysis and definition of CAPA.
- Follow-up implementation of CAPAs and ensure timely completeness.
- Provide responses and address questions and observations during inspection when observations are related to the role or responsibilities of the QA function.
- Coordinate the preparation and conduct of inspection as required.
- ** Quality Objectives**:
- Develop and communicate Corporate Quality Objectives applicable to clinical research.
- Serves as liaison between the Global Quality System department and functional entities involved in clinical research.
- Shares major deviations and serious breaches with the organization to ensure prevention across organization and alignment of CAPA.
**Other**:
- Respect and ensure compliance with applicable EHS regulations and procedures.
- Promote an EHS dynamic within the teams for the proper functioning of the EHS management system.
- Participate in the prevention of accidents at work by carrying out Managerial Safety Visits (MVS) for its employees if applicable.
**KNOWLEDGE, ABILITIES & EXPERIENCE**
**Education / Certifications**:
- Master’s degree or higher in relevant scientific life science or other relevant scientific Qualifications.
**Experience**:
- Minimum: 5 years of relevant experience in pharmaceutical industry including 3 years in GCP quality management.
- knowledge of FDA/EMA global regulat
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