Senior Manager, GCP QA Operations

Join a Dynamic Team in London

Are you ready to shape quality strategy across global clinical development programmes and ensure excellence in GCP compliance from study start to inspection readiness? Join a talented team where you will serve as a key quality representative, collaborating with a diverse range of stakeholders to promote compliant clinical operations and drive quality-focused decision-making across development programmes.

Key Responsibilities

• Ensure compliance with GCP and relevant regulatory requirements for assigned clinical studies and programs.
• Provide quality oversight and ensure consistency in operational methodologies and processes.
• Act as a key partner to cross-functional study teams, offering quality assurance expertise and guidance.
• Monitor quality performance, identify areas for improvement, and promote best practices.
• Review quality agreements and contracts with clinical vendors and partners to ensure compliance.
• Support the preparation and execution of clinical quality plans and risk-based approaches.
• Contribute to inspection readiness activities and provide support during GCP inspections.
• Collaborate with internal and external stakeholders to address compliance issues and implement corrective actions.
• Facilitate the implementation and continuous improvement of clinical and medical quality systems.
• Conduct risk assessments and manage quality events, investigations, and CAPA (Corrective and Preventive Actions).
• Develop and communicate corporate quality objectives related to clinical research.
• Promote a culture of continuous process improvement and quality risk management.

Key Skills and Requirements

• Strong knowledge of GCP, Good Pharmacovigilance Practices (GVP), and Good Pharmacoepidemiology Practices (GPP).
• Experience in managing interventional and non-interventional clinical studies.
• Proven ability to analyze complex problems and develop effective solutions.
• Excellent interpersonal, leadership, and collaboration skills, with the ability to work in a matrix organization.
• Strong customer focus and ability to influence cross-functional teams.
• Proficiency in English (written and spoken).
• A Master's degree or higher in a relevant scientific field is essential; a degree in Quality or a PhD is preferred.
• Willingness to travel up to 20% of the time.

Join a leading life sciences recruiter focused on finding exceptional individuals and matching them with the finest positions across the globe. Your expertise can make a significant impact in ensuring the highest quality standards in clinical research.