Clinical Quality Manager

JR United Kingdom; Stevenage; On-site; GBP 60,000 - 85,000; Full time

Job summary

Une entreprise familiale de premier plan recherche un Clinical Quality Manager (GCP) pour superviser la gestion de la qualité dans les essais cliniques. Ce rôle inclut le développement de systèmes conformes aux normes GCP et la collaboration avec des équipes variées afin d'assurer le succès des programmes cliniques. Avec plus de 5 ans d'expérience requise dans la supervision de la qualité clinique, ce poste est clé pour garantir l'excellence des normes de qualité et de conformité.

Qualifications

• 5+ années d'expérience dans un rôle de supervision de qualité clinique.
• Expérience QA clinique dans l'industrie pharmaceutique requise.
• Compétences solides en communication écrite et verbale.

Responsibilities

• Développer et maintenir un système de gestion de la qualité clinique efficace.
• Collaborer avec des équipes transversales pour soutenir les programmes d'essais cliniques.
• Surveiller le respect des SOP, des directives et des exigences réglementaires.

Skills

Communication

Excellente présentation

Collaboration

Education

Bachelor's Degree (Science discipline preferred)

Job description

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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.