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.
* Strong project management skills.
* 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 +44 (20) 3769 7178 for a confidential discussion.