Compliance / Quality Assurance Manager

Clinical trial SaaS is hiring due to growth!

Responsibilities:

• Ensure Regulatory Compliance: Develop and implement comprehensive quality assurance and compliance programs to ensure adherence to FDA regulations, GCP guidelines, and other relevant standards.
• Validate Systems: Oversee the validation of our SaaS platform, including requirement analysis, test planning, execution, and reporting, to guarantee product quality and reliability.
• Manage Q/A Team and Vendors: Lead a dedicated Q/A team and coordinate with external vendors to ensure efficient and effective quality assurance operations.
• Stay Updated on Industry Trends: Maintain a deep understanding of emerging industry trends, regulatory changes, and technological advancements to drive continuous improvement.
• Collaborate with Cross-Functional Teams: Work closely with development, product management, and other departments to ensure quality throughout the product lifecycle.

Qualifications:

• Proven experience in quality assurance and compliance within the clinical trials industry, with a strong understanding of FDA regulations, GCP guidelines, and industry best practices.
• Expertise in validating SaaS platforms, including requirement analysis, test planning, execution, and reporting.
• Experience managing quality assurance teams and coordinating with external vendors.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Bachelor's degree in a relevant field (e.g., computer science, engineering, life sciences).

Note:

This is a direct hire position. No C2C or contracting.