QA Specialist / QA Manager (Clinical Quality Assurance)

Commitment:Full-Time Contract (30–40 hours per week) Location:Based in India, Remote – Eastern Time Zone (preferred) or Mountain Time Zone Reports To:Clinical QA Lead / Director of QualityPosition Overview We are seeking an experiencedQA Specialist / Manager-level contractorto provide day-to-day clinical quality assurance (QA) support across ongoing clinical trials. This individual will play a key role in guiding study teams, maintaining compliance withGood Clinical Practice (GCP) , and ensuring quality oversight. The ideal candidate brings strong experience withVeeva QMS , is highly tech-savvy, and can support clinical operations teams in a fast-paced, remote environment.Key Responsibilities Serve as the primary QA support resource for clinical study teams, ensuring compliance with GCP and internal quality standards. Provide QA expertise during study calls, including: Protocol deviation meetings Risk-based quality management discussions Study operations and trial oversight meetings Write, review, update, and formatstandard operating procedures (SOPs)and other quality documentation. Manage and track quality processes withinVeeva QMS , including document control, training, and CAPA management. Address QA-related questions from study teams in real time, providing clear and actionable guidance. Support inspection readiness and contribute to continuous improvement of QA systems and processes. Partner with cross-functional stakeholders (Clinical Operations, Data Management, Regulatory, etc.) to align on quality expectations and risk mitigation.Qualifications Education:Bachelor’s degree in life sciences, healthcare, or related discipline (advanced degree preferred). Experience: 5+ years ofClinical Quality Assuranceexperience with a strong foundation in GCP. Prior experience supporting clinical study teams in a QA capacity. Hands-on experience withVeeva QMS . Technical Skills: Proficient in MS Office (Excel, PowerPoint, Word). Skilled in technical writing, SOP drafting, and document formatting. Soft Skills: Excellent communication and interpersonal skills. Strong organizational skills with the ability to work independently. Availability:Must be available duringEastern or Mountain Time Zone working hoursto attend study calls and provide timely QA support.Contract Opportunity This is afull-time contract roleoffering 30–40 hours per week of consistent work. The contractor will act as a core member of the QA function, providing essential support to ongoing clinical programs and ensuring regulatory compliance.

Apply Now