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Senior Director, Quality Assurance and Compliance
hace 2 meses
About Tfs Healthscience
Tfs Healthscience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.
We offer full-service capabilities, resourcing, and Functional Service (FSP) solutions to support our clients' clinical research needs.
Job Summary
We are seeking a highly experienced Senior or Executive Director, Quality and Compliance to join our Quality Assurance team. As a key member of our organization, you will be responsible for ensuring our customers achieve their goals by providing strategic leadership and direction to our Quality Assurance department.
Key Responsibilities
- Leadership and Management: Provide strategic leadership and direction to the Quality Assurance department, responsible for KQI and metrics for Quality Management.
- Quality Management System: Manage the eQMS, including all types of Quality Issues and CAPAs, and contribute to the development and improvement of our Quality Management System.
- Audits and Inspections: Prepare and monitor compliance to the Annual Audit Plan, track all audit types, and ensure all are completed. Host and manage regulatory inspections of Tfs and assist in preparing investigational sites for regulatory inspections.
- Training and Information: Deliver or coordinate delivery of training for Quality Management and all Tfs staff for Quality & Compliance matters, and maintain excellent knowledge of applicable regulations and company GxP standards and procedures.
- Other Quality & Compliance Tasks: Ensure all client or Tfs GxP vendors are assessed, and inform Vendor Management when issues/complaints are raised and work with Vendor Management to resolve these.
Requirements
- University/college degree in life science or equivalent.
- Minimum 10 years' experience in clinical research, including auditing in two to three GxP areas and leadership role.
- Excellent knowledge of GxP regulations and guidance, awareness of global trends, and government policies in the clinical trials area.
- Strong leadership skills, problem-solving, and team management ability.
- Ability to deal effectively with inspectors, sponsors, and internal customers at all levels.
- Willingness and ability to travel.
- Excellent English verbal and written communication skills.
What We Offer
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment.
