Senior Director, Quality & Compliance – Europe

This is a fully remote position, open to applicants in Bulgaria, +5 more countries.

📋 Description

• Collaborate with the EVP, Global Quality to formulate and implement the global quality and compliance strategy.

• Provide leadership for quality management activities throughout all clinical research services.

• Act as a senior member of the Quality Leadership Team and engage in enterprise quality governance initiatives.

• Drive quality transformation and initiatives aimed at enhancing quality maturity.

• Serve as a senior quality representative for clients, sponsors, and strategic partners.

• Lead and develop a team of Quality leads to offer customer-facing support and internal operational collaboration.

• Assist in business development, proposals, bid defenses, due diligence activities, and client governance meetings.

• Present quality metrics, compliance trends, and strategies for quality improvement to clients and executive stakeholders.

• Provide strategic oversight for Quality Management System processes and governance.

• Support the global governance framework related to quality issue management and the effectiveness of CAPA.

• Chair or supervise quality review forums addressing significant quality events, root cause investigations, and remediation efforts.

• Offer executive oversight and strategic assistance for regulatory inspections, sponsor audits, and client assessments.

• Aid in inspection preparation, response strategy, management of observations, CAPA development, and regulatory commitments.

• Keep track of emerging regulatory requirements and industry expectations impacting clinical research organizations.

• Assist executive quality reviews and governance committees by providing data-driven insights and recommendations.

• Evaluate quality and compliance risks while supporting risk mitigation strategies.

• Offer expert consultation to senior leadership on quality, compliance, inspection readiness, and regulatory risk.

• Contribute to enterprise risk management initiatives and quality-related strategic projects.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Nursing, Pharmacy, Quality, Regulatory Affairs, or a related scientific discipline is required.

• Advanced understanding of ICH-GCP, FDA regulations, EMA guidance, MHRA requirements, PMDA expectations, Vendor Governance applicable GxP regulations, Risk Management principles, Computerized Systems and 21 CFR Part 11, Quality Management Systems, and inspection readiness frameworks.

• Strong grasp of the clinical development lifecycle and CRO operations.

• Familiarity with AI in relation to clinical research applications.

• Possess a strategic and enterprise-focused mindset.

• Demonstrate a strong customer orientation and relationship management abilities.

• Exhibit exceptional communication skills and executive presence.

• Ability to influence across all levels of the organization.

• High integrity, accountability, and dedication to quality excellence.

• At least 10-15 years of progressive experience in Quality Assurance, Quality Management, Regulatory Compliance, or Clinical Research.

• A minimum of 7 years of leadership experience managing global teams.

• Significant experience in CRO, pharmaceutical, biotechnology, or clinical research settings.

🏝️ Benefits

• Equal employment opportunities.

• Diverse and inclusive work environment.

• Supportive and collaborative teams.

• Opportunities for professional growth and success.