Head of Quality Assurance

Job not on LinkedIn

🕒 May 5

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

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Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.

📋 Description

• Lead and evolve Cytel’s global Quality Assurance strategy in alignment with business growth and regulatory expectations • Oversee, maintain, and continuously enhance the Quality Management System (QMS) • Serve as a senior leader during sponsor audits and regulatory inspections • Drive modernization of QA through adoption of digital tools, automation, and AI-enabled solutions • Improve consistency and reduce variability in audit readiness, execution, and responses • Partner closely with operational and functional teams to embed quality into day-to-day execution • Streamline QA processes to reduce unnecessary burden while maintaining robust compliance • Build, mentor, and develop a high-performing global QA team

🎯 Requirements

• Significant experience in Quality Assurance within a CRO, pharmaceutical, or biotechnology environment • Strong expertise in GxP regulations and audit/inspection processes • Proven experience leading sponsor audits and regulatory interactions • Demonstrated success in improving and modernizing QA processes • Experience leveraging technology, automation, or AI to enhance quality systems strongly preferred, with an emphasis on practical, fit-for-purpose solutions rather than large-scale transformation initiatives • Strong business acumen and the ability to influence and partner effectively with senior stakeholders

🏖️ Benefits

• Opportunity to build on a strong foundation and position Quality as a competitive advantage • High-impact leadership role with visibility across the organization and with clients • Collaborative environment with deeply experienced operational teams • Meaningful opportunity to shape a modern, scalable, technology-enabled quality function