
Clinical Quality Assurance Expert
22 hours ago
We are seeking a skilled Quality Assurance Professional to join our team. As a key member of our QA function, you will play a vital role in ensuring the quality and integrity of our clinical programs.
About the RoleThis is a full-time contract position that requires 30-40 hours of work per week. You will be responsible for guiding study teams and providing day-to-day clinical quality assurance support to ensure compliance with Good Clinical Practice (GCP).
Key Responsibilities- Ensure compliance with GCP and internal quality standards as the primary QA support resource for clinical study teams.
- Provide QA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, and study operations and trial oversight meetings.
- Develop and maintain standard operating procedures (SOPs) and other quality documentation to ensure alignment with company policies and industry regulations.
- 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.
- Bachelor's degree in life sciences, healthcare, or related discipline.
- A minimum of 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.
- Excellent communication and interpersonal skills, with the ability to work independently and collaboratively as part of a team.
This is a unique opportunity to join a dynamic team and make a meaningful contribution to the success of our organization. If you are a motivated and detail-oriented individual who is passionate about quality assurance, we encourage you to apply.
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