Head of Quality Assurance

Clinical Outcomes Solutions

Head of Quality Assurance leading global quality function to enhance scalability and effectiveness. Focused on automation and technology in regulatory compliance for Cytel.

Posted 5/5/2026full-timeRemote • 🇺🇸 United StatesLeadWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Quality AssuranceQuality Management SystemGxP regulationsaudit processesinspection processesautomationAI-enabled solutionsprocess improvementdigital toolscompliance

Soft Skills

leadershipmentoringinfluencingcollaborationbusiness acumencommunicationteam developmentstrategic thinkingproblem-solvingstakeholder engagement