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 OverviewWe are seeking an experienced QA Specialist / Manager-level contractor to 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 with

Good Clinical Practice (GCP), and ensuring quality oversight. The ideal candidate brings strong experience with Veeva QMS, is highly tech-savvy, and can support clinical operations teams in a fast-paced, remote environment. Key ResponsibilitiesServe 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 format standard operating procedures (SOPs) and other quality documentation. Manage and track quality processes within Veeva 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. QualificationsEducation: Bachelors degree in life sciences, healthcare, or related discipline (advanced degree preferred).

Experience:5+ years of Clinical Quality Assurance experience with a strong foundation in GCP.Prior experience supporting clinical study teams in a QA capacity. Hands-on experience with Veeva QMS.Technical Skills:Proficient in MS Office (Excel, Power Point, 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 during Eastern or Mountain Time Zone working hours to attend study calls and provide timely QA support.

Contract OpportunityThis is a full-time contract role offering 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.

Information :

• Company : K3-Innovations, Inc.
• Position : Qa specialist / qa manager (clinical quality assurance)
• Location : Jāmnagar, Gujarāt
• Country : IN