Senior Director, Quality Assurance and Compliance

hace 3 días

Barcelona, Barcelona, España Tfs Healthscience A tiempo completo
About the Role

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 Summary

We are seeking a highly experienced Senior Director, Quality Assurance and Compliance to join our Quality Assurance team. As a key member of our leadership team, you will be responsible for ensuring our customers achieve their goals by providing strategic leadership and direction to our Quality Assurance department.

Key Responsibilities:
  • Provide strategic leadership and direction to the Quality Assurance department.
  • Responsible for KQI and metrics for Quality Management.
  • Coordinate and oversee that global procedures such as Standard Operating Procedures are available, up-to-date, and compliant with appropriate guidelines and legislation.
  • Re-develop processes and practices to optimize compliance, consumption, and efficiency.
  • Act as a Business System and Business Process Owner as delegated.
  • 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.
  • Oversee time reporting and expenses.
  • Coach, support, and mentor staff.
  • Develop and plan training as necessary, plus contribute to individual career development and goal setting.
  • Ensure succession planning by developing skills in staff to ensure good coverage and excellent performance for all QC activities, audit/inspection, and sales representation.
  • Ensure that global operational deliverables are conducted in accordance with Tfs Healthscience quality standards.
  • Ensure any company initiatives are measured, tracked, and completed on time, with clear return-on-investment.
  • Support cost model development, pre-sales events, RFP, RFI, and post-award input (e.g., MSAs) in relation to Quality Compliance.
  • Provide quality management advice and support to all internal staff and departments.
  • Work constructively and responsively with Heads of Departments, senior staff, and other partners to better achieve company goals and create a positive working environment.
  • Host QIS Council meetings on a quarterly basis.
  • Audits: Responsible for preparing and monitoring compliance to the Annual Audit Plan.
  • Responsible for tracking all audit types and ensuring all are completed.
  • Prepare, conduct, and follow up on internal and external GxP audits.
  • Responsible for hosting/facilitating customer audits of the company and/or projects.
  • Review audit reports for other quality management personnel and provide advice and direction as required.
  • Inspections: Responsible for hosting and managing regulatory inspections of Tfs Healthscience.
  • Assist in preparing investigational sites for regulatory inspections, as required.
  • Host regulatory inspections for clients, as required.
  • Quality Management System: Responsible for the management of the eQMS including all types of Quality Issues and CAPAs.
  • Contribute and coordinate so that Complaints, Potential Serious Breach, and Potential Fraud and Scientific Misconduct investigations are finalized in compliance with Tfs Healthscience applicable SOPs.
  • Responsible for the development and improvement of Tfs Healthscience Quality Management System.
  • Responsible for ensuring all teams across the organization receive appropriate facilitation to prepare new and update all types of QMS Documents.
  • Responsible for developing new and updating quality management QMS Documents, as required, and ensuring high quality in all published SOPs, policies, and other documentation inline with appropriate guidelines and legislation.
  • Deliver or coordinate delivery of training for Quality Management and all Tfs Healthscience staff for Quality Compliance matters.
  • Responsible for ensuring Regulatory Intelligence is maintained and disseminated to the whole company (excluding Regulatory Process information).
  • Maintain excellent knowledge of applicable regulations and company GxP standards and procedures.
  • Other Quality Compliance tasks: Responsible for ensuring all client or Tfs Healthscience GxP vendors are assessed.
  • Responsible for informing Vendor Management when issues/complaints are raised and working with Vendor Management to resolve these.
  • Other activities as delegated.
Qualifications:
  • University/college degree in life science or equivalent.
  • Minimum 10 years' experience in clinical research (e.g., monitoring, data management, drug safety, training, etc.).
  • Minimum 10 years' experience of auditing in two to three GxP areas.
  • Minimum 10 years in leadership role.
  • Excellent knowledge of GxP regulations and guidance.
  • Awareness of global trends, and government policies in the clinical trials area.
  • Experience in driving the quality and compliance within CROs and their regulatory requirements.
  • Strong leadership skills, problem-solving, and team management.
  • 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.
  • Fluency in other languages will be considered as an advantage.

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