Mantell Associates is partnered with a leading pharmaceutical manufacturing company, in their search for a GCP / Clinical Quality Director to join their team in November 2025.
In this role, you will oversee and ensure the implementation of robust quality systems and processes within the clinical operations of the company.
GCP / Clinical Quality Director - Responsibilities:
* Lead and manage the company's clinical quality assurance activities to ensure compliance with GCP, regulatory requirements, and internal standards
* Supervise and mentor a team of clinical quality assurance professionals, fostering a culture of continuous improvement and high performance
* Coordinate and lead internal and external clinical audits, addressing any findings and implementing corrective actions as necessary
* Oversee the review and approval of clinical trial documentation, including protocols, informed consent forms, and clinical study reports, ensuring accuracy and compliance
* Ensure the company maintains compliance with all relevant regulatory agencies, including the EMA and FDA, and support regulatory inspections
* Drive initiatives to enhance clinical quality systems, processes, and training programs to support operational excellence
GCP / Clinical Quality Director - Requirements:
* Minimum of 8 years' experience in clinical quality assurance within a pharmaceutical or biotechnology environment, with a strong background in GCP compliance
* Degree in Life Sciences, Pharmacy, or a related field
* In-depth understanding of GCP, regulatory requirements, and clinical trial processes
* Excellent leadership, communication, and problem-solving skills
* Fluency in English is required; proficiency in German is advantageous
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.