Senior Director, Quality Assurance and Compliance

hace 5 días

Madrid Centro, Madrid, España TFS HealthScience A tiempo completo
About This Role

We are seeking a highly experienced and skilled Senior or Executive Director to lead our Quality Assurance and Compliance department at TFS HealthScience. As a key member of our team, you will be responsible for ensuring the highest standards of quality and compliance across our organization.

Key Responsibilities
  1. Leadership and Management: Provide strategic leadership and direction to the Quality Assurance department, ensuring the development and implementation of effective quality management systems and processes.
  2. Develop and implement strategies to optimize compliance, efficiency, and quality across the organization.
  3. Act as a Business System and Business Process Owner, ensuring the development and maintenance of business processes and systems that support quality and compliance.
  4. Lead and manage a team of quality professionals, providing guidance, coaching, and development opportunities to ensure the success of the department.
  5. Oversee the development and implementation of quality management systems, including the management of quality issues and CAPAs.
  6. Ensure the development and maintenance of quality management documents, including SOPs, policies, and procedures.
  7. Provide quality management advice and support to internal staff and departments, ensuring that quality and compliance standards are met.
  8. Work collaboratively with other departments to ensure the effective implementation of quality and compliance initiatives.
  9. Host and manage regulatory inspections, audits, and other quality-related activities.
  10. Develop and implement training programs to ensure that quality and compliance standards are met.
  11. Ensure the effective management of vendor relationships, including the assessment and management of vendor risks.
Requirements
  1. University/college degree in life science or equivalent.
  2. Minimum 10 years' experience in clinical research, including auditing and quality management.
  3. Minimum 10 years' experience in a leadership role, with a proven track record of success in quality and compliance.
  4. Excellent knowledge of GxP regulations and guidance.
  5. Awareness of global trends and government policies in the clinical trials area.
  6. Experience in driving quality and compliance within CROs and their regulatory requirements.
  7. Strong leadership skills, problem-solving, and team management.
  8. Ability to deal effectively with inspectors, sponsors, and internal customers at all levels.
  9. Willingness and ability to travel.
  10. Excellent English verbal and written communication skills. Fluency in other languages will be considered as an advantage.
What We Offer

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.

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