Senior Clinical Quality Assurance Associate

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

Company

hirify.global partners with biopharmaceutical sponsors to provide clinical trial delivery, home health services, expanded access programs, clinical trial supply, and market access consultancy.

What you will do

• Serve as a GCP quality systems subject matter expert across global clinical operations.
• Provide QA oversight to Clinical Operations, Nursing, Project Management, Medical Affairs, Pharmacovigilance, Regulatory Affairs, and other operational teams.
• Lead investigations into non-conformances, complaints, protocol deviations, quality events, and compliance issues.
• Manage complex CAPAs from root-cause investigation through effectiveness checks and closure.
• Lead risk assessments and review clinical and GCP documentation, including protocols, informed consent forms, eCRFs, monitoring plans, and essential documents.
• Support decentralized clinical trial activities, vendor quality management, audits, inspections, quality metrics, validation activities, and continuous improvement initiatives.

Requirements

• Bachelor’s degree or higher, preferably in pharmaceuticals, life sciences, or engineering.
• 3–5 years of quality-related experience in a CRO, pharmaceutical, biotechnology, or healthcare organization.
• Experience supporting global clinical trials, decentralized clinical trial activities, and sponsor, regulatory, internal, or supplier audits.
• Practical experience with quality investigations, CAPAs, root-cause analysis, risk assessments, and continuous improvement.
• Experience with eQMS, eTMF, Microsoft Office, quality management software, GCP regulations, ICH E6(R3), FDA, EU Clinical Trial Regulation, MHRA, and applicable GDPR requirements.
• Strong understanding of quality management systems, risk-based quality management, computerized system validation principles, communication, stakeholder management, mentoring, and influencing.

Nice to have

• Practical understanding of GDP, warehousing, logistics, and clinical trial supply processes.

Culture & Benefits

• Medical, dental, and vision insurance.
• FSA, HSA, disability, life, critical illness, hospital indemnity, and accident insurance options.
• 401(k) safe harbor plan with company match.
• Paid vacation, holidays, sick time, volunteer time, and maternity and paternity leave.
• Inclusive, supportive environment focused on integrity, accountability, wellness, professional development, and collaboration.

Hiring process

• Submit a resume in English through the hirify.global Careers Portal or LinkedIn Easy Apply.
• An Upwage AI screener may be used as part of the application process, followed by human review and interviews.