Senior Director, Quality & Compliance – Europe

🕒 il y a 6 jours

🌐 Bulgarie, Espagne, +4 autres pays – Distant

🇧🇬 Bulgarie – Télétravail 🇪🇸 Espagne – Télétravail 🇵🇱 Pologne – Télétravail 🇭🇷 Croatie – Télétravail 🇬🇧 Royaume-Uni – Télétravail 🇷🇴 Roumanie – Télétravail

⏰ Temps Plein

🟠 Senior

🚔 Conformité

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Worldwide Clinical Trials

Site WebLinkedInTous les Emplois

1001 - 5000 employés

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Worldwide Clinical Trials est une organisation mondiale de recherche contractuelle (CRO) qui offre des services complets d'essais cliniques. Ils se spécialisent dans le soutien aux études dans divers domaines thérapeutiques tels que l'oncologie, la cardiologie et les maladies rares. Avec plus de 30 ans d'expérience, Worldwide Clinical Trials met l'accent sur un soutien personnalisé et des solutions sur mesure tout au long du cycle de développement des médicaments. Leurs services incluent la surveillance clinique, la gestion des données, le recrutement de patients et le conseil réglementaire, garantissant précision et attention sur-mesure pour chaque essai clinique.

Description

• Partner with the EVP, Global Quality to develop and execute the global quality and compliance strategy • Provide leadership for quality management activities across all clinical research services • Serve as a senior member of the Quality Leadership Team and contribute to enterprise quality governance initiatives • Lead quality transformation and quality maturity initiatives • Act as a senior quality representative for clients, sponsors, and strategic partners • Lead and grow a team of Quality leads providing customer-facing support and internal operational partnership • Support business development, proposals, bid defences, due diligence activities, and client governance meetings • Present quality metrics, compliance trends, and quality improvement strategies to clients and executive stakeholders • Provide strategic oversight of Quality Management System processes and governance • Support the global governance framework for quality issue management and CAPA effectiveness • Chair or oversee quality review forums covering significant quality events, root cause investigations, and remediation activities • Provide executive oversight and strategic support for regulatory inspections, sponsor audits, and client assessments • Support inspection preparation, response strategy, observation management, CAPA development, and regulatory commitments • Monitor emerging regulatory requirements and industry expectations affecting clinical research organisations • Support executive quality reviews and governance committees through data-driven insights and recommendations • Assess quality and compliance risks and support risk mitigation strategies • Provide expert consultation to senior leadership on quality, compliance, inspection readiness, and regulatory risk • Contribute to enterprise risk management activities and quality-related strategic initiatives

🎯 Exigences

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Quality, Regulatory Affairs, or related scientific discipline required • Advanced knowledge of ICH-GCP, FDA regulations, EMA guidance, MHRA requirements, PMDA expectations, Vendor Governance applicable GxP regulations, Risk Management principles, Computerised Systems and 21 CFR Part 11, Quality Management Systems, and inspection readiness frameworks • Strong understanding of the clinical development lifecycle and CRO operations • Understanding of AI as applies to clinical research applications • Strategic and enterprise mindset • Strong customer focus and relationship management skills • Exceptional communication and executive presence • Ability to influence at all organisational levels • High integrity, accountability, and commitment to quality excellence • Minimum 10-15 years of progressive experience in Quality Assurance, Quality Management, Regulatory Compliance, or Clinical Research • Minimum 7 years of leadership experience managing global teams • Significant experience within CRO, pharmaceutical, biotechnology, or clinical research environments

🏖️ Avantages

• Equal employment opportunities • Diverse and inclusive work environment • Supportive and collaborative teams • Professional growth and opportunity to succeed