
Senior Clinical Quality Assurance Manager
1 day ago
Clinical Quality Assurance Specialist
">We are seeking an experienced Clinical Quality Assurance (CQA) professional to provide day-to-day 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 Responsibilities
">- Serve as the primary CQA resource for clinical study teams, ensuring compliance with GCP and internal quality standards.">
- Provide CQA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, study operations and trial oversight meetings, and more.">
- 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 CQA-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.">
Required Skills and Qualifications
">- Bachelor's degree in life sciences, healthcare, or related discipline (advanced degree preferred).">
- 5+ years of Clinical Quality Assurance experience with a strong foundation in GCP.">
- Prior experience supporting clinical study teams in a CQA capacity.">
- Hands-on experience with Veeva 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.">
Benefits
">This 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.
">Award-winning company
">We offer a collaborative and dynamic work environment that fosters growth and development. Our team members enjoy a range of benefits, including competitive compensation, comprehensive benefits, and opportunities for professional advancement.
"]],-
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