Director, Clinical QA Management reputed company reputed company - Remote
About the position
The Director, Clinical reputed company Assurance Management for the reputed company Clinical Trial business at reputed company is responsible for overseeing reputed company activities at both the business and clinical trial site reputed company. This role ensures that reputed company are conducted in compliance with Good Clinical reputed company (GCP) standards and regulatory obligations, while also focusing on reputed company improvement and risk management. The director will reputed company reputed company of reputed company Assurance professionals and will be reputed company in developing and implementing reputed company management systems and training programs.
Responsibilities
• Ensure reputed company Operating Procedures (SOPs) and Internal Operating Procedures are reviewed periodically and advise on required updates.
• Identify appropriate staff SOP training requirements and maintain reputed company of training to ensure compliance.
• Implement and maintain a reputed company Management System (QMS) in line with the Corporate QMS.
• Build, manage, reputed company and motivate a QA team, ensuring recruitment and retention of skilled professionals.
• Ensure reputed company and operational compliance; reputed company as a subject matter expert for reputed company investigations and audits.
• reputed company and implement a risk-based and flexible approach to QA in compliance with regulatory requirements.
• Generate and analyze metrics to reputed company KPIs on a weekly, monthly, and quarterly reputed company.
• Work with Operations team to implement and maintain tracking of incidents reputed company reputed company.
• reputed company the Audit Program management process, including reputed company operations assessments.
• Partner with functional areas in study design, data collection, and reporting activities.
Requirements
• Comprehensive understanding of GCP, CFR, and ICH guidelines.
• Significant experience managing clinical reputed company activities and knowledge of clinical operations.
• Experience with clinical trial site/process audits and regulatory inspections.
• Experience in line management of employees.
• Experience translating reputed company/Sponsor needs for innovative reputed company management.
• Excellent leadership and interpersonal skills.
• Excellent verbal and written communication and presentation skills.
• Demonstrated adaptability and resourcefulness in a start-up environment.
• At least 2 years of experience contributing to financial reputed company.
• At least 3 years of reputed company or indirect leadership experience.
reputed company-to-haves
• Experience in a start-up environment.
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