Director, Quality Assurance
ICON plcICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We are currently seeking a Director Quality Assurance to join our diverse and dynamic team. As a Director Quality Assurance at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of innovative treatments and therapies.
What you will be doing
- Leading the development and implementation of quality assurance strategies and processes to support clinical trial activities.
- Conducting comprehensive quality assessments and audits to ensure compliance with regulatory standards and guidelines.
- Collaborating with cross-functional teams to identify and address quality issues and implement corrective actions as needed.
- Providing expert guidance and support to staff regarding quality assurance policies, procedures, and best practices.
- Contributing to the continuous improvement of quality management systems and documentation.
Your profile
- Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
- Minimum of 10 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with significant experience in a leadership role.
- Extensive knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).
- Strong analytical and problem-solving skills, with the ability to identify and resolve complex quality issues.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
Nous recherchons actuellement un(e) Directeur(trice) Assurance Qualité pour rejoindre notre équipe diversifiée et dynamique. En tant que Directeur(trice) Assurance Qualité chez ICON, vous jouerez un rôle clé dans la garantie de la qualité et de la conformité des essais cliniques, dans l’interprétation des exigences réglementaires et dans la contribution à l’avancement de traitements et thérapies innovants.
Vos missions
Diriger le développement et la mise en œuvre des stratégies et des processus d’assurance qualité afin de soutenir les activités liées aux essais cliniques.
Réaliser des évaluations qualité complètes et des audits afin de garantir la conformité aux normes et directives réglementaires.
Collaborer avec des équipes transverses pour identifier et résoudre les problématiques qualité, et mettre en place des actions correctives si nécessaire.
Fournir des conseils et un accompagnement d’expert aux équipes concernant les politiques, procédures et meilleures pratiques en matière d’assurance qualité.
Contribuer à l’amélioration continue des systèmes de management de la qualité et de la documentation associée.
Votre profil
Diplôme de niveau Licence (Bachelor) en Sciences de la Vie, Pharmacie ou domaine connexe ; diplôme supérieur souhaité.
Minimum de 10 ans d’expérience en assurance qualité dans l’industrie pharmaceutique, biotechnologique ou au sein d’une CRO, avec une expérience significative à un poste de leadership.
Connaissance approfondie des exigences et réglementations encadrant les essais cliniques (ex. ICH-GCP, réglementations FDA).
Excellentes capacités d’analyse et de résolution de problèmes, avec aptitude à identifier et résoudre des problématiques qualité complexes.
Excellentes compétences en communication et en relations interpersonnelles, avec la capacité de collaborer efficacement avec des équipes transverses et différentes parties prenantes.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply