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Senior Director, Quality and Compliance
hace 2 meses
Tfs Healthscience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.
Job SummaryWe are seeking a highly experienced Senior or Executive Director, Quality and Compliance to join our Quality Assurance team. As a key member of our leadership team, you will be responsible for the Quality Assurance department and Quality & Compliance direction across Tfs Healthscience.
Key Responsibilities- Leadership and Management: Provide strategic leadership and direction to the Quality Assurance department.
- Quality Management: Responsible for KQI and metrics for Quality Management.
- Compliance: Coordinate and oversee that global procedures such as Standard Operating Procedures are available, up-to-date, and compliant with appropriate guidelines and legislation.
- Process Improvement: Re-develop processes and practices to optimize compliance, consumption, and efficiency.
- Business System and Business Process Ownership: Act as a Business System and Business Process Owner as delegated.
- Leadership and Line Management: Overall leadership and line management for assigned staff and department, including resource planning, recruitment of new staff, performance review, training, disciplinary procedures, and administrative activities.
- Vendor Management: Responsible for ensuring all client or Tfs Healthscience GxP vendors are assessed.
- Regulatory Intelligence: Maintain excellent knowledge of applicable regulations and company GxP standards and procedures.
- Qualifications: University/college degree in life science or equivalent.
- Experience: Minimum 10 years' experience in clinical research (e.g. monitoring, data management, drug safety, training, etc.).
- Leadership Experience: Minimum 10 years' experience of auditing in two to three GxP areas and minimum 10 years in leadership role.
- Skills: Excellent knowledge of GxP regulations and guidance, awareness of global trends, and government policies in the clinical trials area.
- Language Skills: Excellent English verbal and written communication skills. Fluency in other languages will be considered as an advantage.
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.
