Quality Assurance Manager in Clinical Trials/Менеджер по качеству в клинических исследованиях

09 Ноября 2024

Astellas Pharma

Город:

Москва

Занятость:

Полная занятость

Опыт:

Нет опыта

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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.

Professional Profile:

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).