Senior Clinical Quality Assurance Associate (Pharmaceutical)

TL;DR

Senior Clinical Quality Assurance Associate (Pharmaceutical): Oversight and implementation of GCP quality systems supporting global clinical operations with an accent on decentralized clinical trials (DCTs) and regulatory compliance. Focus on leading investigations for non-conformances, managing complex CAPAs, and ensuring adherence to ICH GCP and global regulatory requirements.

Location: Remote (US). Must reside in a U.S. state where the company is authorized to hire. Not eligible for residents of California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia.

Company

hirify.global partners with biopharmaceutical Sponsors to deliver end-to-end clinical trials, home health services, and market access consultancy.

What you will do

• Serve as a GCP quality systems SME for global clinical operations.
• Provide QA oversight to Clinical Operations, Nursing, Project Management, and Medical Affairs.
• Lead investigations for non-conformances, protocol deviations, and quality events.
• Manage complex CAPAs from investigation through closure and effectiveness checks.
• Conduct risk assessments for new services, vendors, and operational changes.
• Oversee DCT activities, including home healthcare and IP handling.

Requirements

• Bachelor's Degree in pharmaceutical, life sciences, or engineering.
• 3-5 years of experience in a quality role within a CRO, pharma, or biotech organization.
• Experience supporting global clinical trials and decentralized clinical trial (DCT) activities.
• Proficiency in quality investigations, CAPAs, root cause analysis, and risk assessments.
• Working knowledge of GCP regulations including ICH E6(R3), FDA, EU CTR, MHRA, and GDPR.
• Experience with eQMS, eTMF, and quality management software.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401K safe harbor plan with company match.
• Paid vacation, holiday, sick, and volunteer time.
• Paid maternity and paternity leave.
• FSA and HSA options.

Hiring process

• Resume submission via Careers Portal or LinkedIn.
• Initial screening using an Upwage AI screener.
• Interviews with the team following successful screening.