Quality Manager

Clinical studies/Programs:

• 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

Maintain a robust Clinical and medical QMS:

• 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.

Compliance activities:

- 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.

- Inspections:

• 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

- Audits:

• 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 raised

Quality Objectives:

• 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 with the organization and ensure prevention across organization and alignment of CAPA

EHS Responsibility:

• 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

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