
Clinical Quality Assurance Expert
2 days ago
This role offers an opportunity to work as a key member of our clinical quality assurance team, providing expert guidance and support to study teams on Good Clinical Practice (GCP) compliance.
- Main Responsibilities:
- Serve as the primary QA support resource for clinical study teams, ensuring adherence to GCP and internal quality standards.
- Collaborate with cross-functional stakeholders to align on quality expectations and risk mitigation.
- Partner with study teams to address QA-related questions, provide clear and actionable guidance, and contribute to continuous improvement of QA systems and processes.
- Develop and maintain quality documentation, including standard operating procedures (SOPs), training materials, and CAPA management.
- Support inspection readiness and lead quality initiatives to drive business growth and improvement.
- Education:
- Bachelor's degree in life sciences, healthcare, or related field; advanced degree preferred.
- Experience:
- Minimum 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 and proficiency in MS Office (Excel, PowerPoint, Word).
- Technical Skills:
- Excellent communication and interpersonal skills.
- Strong organizational skills with the ability to work independently.
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