Clinical Quality Assurance Manager

TL;DR

Clinical Quality Assurance Manager (GCP/QMS): Leading and improving the Good Clinical Practice quality management system supporting global clinical operations and decentralized clinical trials, with an accent on regulatory compliance, risk management, audits, and patient safety. Focus on overseeing investigations and CAPAs, preparing for Sponsor and regulatory inspections, managing vendor quality, and strengthening quality systems across nursing and in-home patient care services.

Location: Remote within the United States. Candidates must reside in a U.S. state where hirify.global is authorized to hire. This role is not available to residents of California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, or the District of Columbia.

Company

hirify.global provides end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy for biopharmaceutical Sponsors.

What you will do

• Lead Clinical Quality team activities, including planning, prioritization, coaching, training, and professional development.
• Provide strategic quality oversight for the GCP Quality Management System across global clinical operations and decentralized clinical trials.
• Oversee deviations, non-conformances, complaints, investigations, CAPAs, change controls, risk assessments, and quality metrics.
• Lead quality oversight for clinical documentation, vendors, new services, computerized systems, equipment, and process validation.
• Prepare for and manage Sponsor audits, regulatory inspections, licensing inspections, and client qualification audits.
• Drive continuous improvement, risk-based decision-making, quality governance, compliance, and patient safety.

Requirements

• Bachelor’s degree or higher, preferably in pharmaceuticals, life sciences, or engineering.
• 5–7 years of experience in a clinical quality role, including experience in a CRO, pharmaceutical, biotechnology, healthcare, or other regulated clinical environment.
• Experience leading or supporting global clinical trials, decentralized clinical trial activities, audits, inspections, investigations, CAPAs, root cause analyses, and quality risk assessments.
• At least 2–3 years of people leadership or supervisory experience is preferred.
• Knowledge of ICH E6(R3), FDA, EU CTR, MHRA, GCP, GDPR, risk-based quality management, computerized system validation, and validation lifecycle principles.
• Strong organization, communication, analytical, stakeholder management, influencing, and project management skills.

Culture & Benefits

• Remote work with a collaborative, inclusive, and supportive environment.
• Medical, dental, and vision insurance, plus FSA and HSA options.
• Short- and long-term disability, life, critical illness, hospital indemnity, and accident insurance.
• 401(k) safe harbor plan with company match.
• Paid vacation, holidays, sick and volunteer time, and maternity and paternity leave.
• Initiatives supporting wellness, professional growth, development, and team relationships.

Hiring process

• Submit an English-language resume through the hirify.global Careers Portal or LinkedIn Easy Apply.
• An Upwage AI screener may be used as part of the application process.
• Selected candidates proceed to interviews with the hirify.global team.