Quality Assurance Manager in Clinical Trials/Менеджер по качеству в клинических исследованиях
30 Сентября 2024
Город:
Москва
Занятость:
Полная занятость
Опыт:
Нет опыта
Компания "Astellas Pharma"
Responsibilities:- Acts as a key country Sponsor’s Quality contact.
- Establish, implement and maintain the Sponsor’s Quality Management System within respective field of clinical trials ensuring applicable Global and Regional Policies and SOPs are incorporated into local procedures.
- Ensure that all localized computerized solutions and electronic interfaces used for GCP purposes are validated, if any.Vendor Selection & quality oversight as required, quality agreement management.
- Quality oversight and approval of the clinical trials documentation as required.Prepare for, host and respond to GCP Inspections by Competent Authorities along with CRO staff and global cross-functional teams, report results as per Astellas procedures.
- Prepare for, overall support of GCP inspections of clinical sites by Competent Authorities along with CRO staff and global cross-functional teams, report results as per Astellas procedures.
- Prepare for, host and respond to QA Internal audits along with CRO staff and global cross-functional teams, determine root cause for any identified non-conformities and establish and agree corrective action plans.
- Ensure that deviations as identified within respective field are raised in corporate system, appropriately investigated and CAPA plans developed where appropriate.
- Collaborate and communicate closely with cross-functional teams both at global and affiliate level, stakeholders within clinical trials to ensure proper execution and conduct the study effectively.
- Ensure that management within clinical trials is kept informed of any potential Significant Quality Issues.
- Other tasks as assigned related to study deliverables.
- Science based degree in biological sciences, Pharmacy and allied domains.
- Extensive experience in progressively complex comparable managerial roles in the clinical trials.
- Demonstrate personal and intellectual capacity to command the respect colleagues in a highly diverse environment as well as Authorities and Suppliers.
- Quality Assurance experience within the clinical trials is essential.
- Good organizational, coordination, diplomatic, negotiation, presentation and communications.
- Fluency in written and spoken English.
- Common Sense approach to work.
- Analytical approach to problem solving.
- Ability to contribute to appropriate processes.
- Good communication skills, both written and spoken, are necessary.
- Awareness of Corporate politics and able to manage with sensitivity key stakeholders from diverse cultural and professional backgrounds.
- Understanding of regional GCP requirements and directives.
- GCP auditing experience.
- Able to undertake approximately 20 – 30% business travel (including staying away).
Working conditions:
- Competitive salary.
- Health Insurance.
- Meal allowance.
- Work in a friendly team in one of the successful and rapidly growing pharmaceutical companies.
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