Senior Director, Quality & Compliance – Europe

🔥 14 hours ago

🌐 Bulgaria, Spain, +4 more countries – Remote

🇧🇬 Bulgaria – Remote 🇪🇸 Spain – Remote 🇵🇱 Poland – Remote 🇭🇷 Croatia – Remote 🇬🇧 United Kingdom – Remote 🇷🇴 Romania – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

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