Clinical Quality Manager

JR United Kingdom; Bournemouth; On-site; GBP 60,000 - 80,000; Full time

Job summary

Une entreprise innovante recherche un Clinical Quality Manager (GCP) pour superviser les systèmes de qualité clinique à l'échelle mondiale. Vous serez responsable de la gestion des audits, de la conformité GCP et de l'amélioration des processus cliniques. Ce poste joue un rôle clé pour garantir la qualité des essais cliniques et le respect des réglementations tout en travaillant en collaboration avec des équipes multifonctionnelles.

Qualifications

• 5+ années d'expérience dans un rôle de supervision de la qualité clinique.
• Expérience en audits et processus de contrôle de la qualité dans les domaines GxP.
• Compétences en communication écrite et verbale solides.

Responsibilities

• Développer et maintenir un système de gestion de la qualité clinique efficace.
• Contribuer à l'amélioration continue des processus cliniques et des procédures opérationnelles standard.
• Gérer les audits des sites d'investigation et garantir la conformité aux réglementations.

Skills

Communication

Collaboration

Auditing

Quality oversight

Education

Bachelor's Degree in a Science discipline

Job description

Social network you want to login/join with:

For over a century and five generations, this family-owned company has been dedicated to improving lives through innovative healthcare solutions, particularly in hormonal treatments for women's and men's health.

Now seeking a Clinical Quality Manager (GCP), the company continues to build on its legacy of pioneering breakthroughs. Over the past 20 years, they have expanded into a global operation with a direct presence in 22 countries and a multicultural team of 1,500 employees worldwide - having doubled in size in recent years. Generating $500 million in annual revenues, their remarkable growth is driven by a commitment to innovation, diversity, and a deep understanding of what truly matters to patients and their families.

The Position

• Develop and maintain an effective clinical quality management system to oversee investigational sites and vendors.
• Collaborate with cross-functional teams (Clinical Operations, Project Management Office, Medical, Regulatory, Pharmacovigilance, etc.) to support clinical trial programs for both new products and new indications of marketed products.
• Ensure GCP/ICH-compliant systems and processes are established and maintained to uphold the quality of clinical trials conducted globally and locally, as needed.
• Contribute to the development, review, and continuous improvement of clinical processes and Standard Operating Procedures (SOPs).
• Monitor adherence to applicable SOPs, guidelines, and regulatory requirements across clinical activities.
• Oversee inspection readiness efforts, including planning and coordination of inspection-related activities.
• Assess and qualify Clinical Research Organizations (CROs) and other vendors involved in clinical operations.
• Develop audit plans, and conduct investigator site audits to ensure compliance with protocols, Good Clinical Practice (GCP), and applicable regulations.
• Oversee CRO and investigator monitoring activities to ensure alignment with protocols, GCP, regulatory requirements, and internal policies.
• Manage quality records, including change controls, investigations, deviations, and Corrective and Preventive Actions (CAPAs), ensuring timely resolution and closure.

The Person

• Bachelor's Degree (Science discipline preferred).
• 5+ years' experience in a Clinical Quality oversight role.
• Clinical QA experience in the pharmaceutical industry essential.
• Experience in audits and/or quality oversight processes in GxP areas.
• Experience carrying out regulatory inspections.
• You work independently as well as collaboratively with cross functional teams.
• Strong communication skills both written and verbal.
• Excellent presentation and training skills.

To learn more about this role apply online or contact Anita Osibuamhe on [phone] for a confidential discussion.