R&D Quality & Audit Specialist - Hybrid/Remote

Ledgent Technology; Alameda (CA); Hybrid; USD 114,616,000 - 126,078,000; Full time

Job summary

Quality Compliance Specialist – Onsite in Canada is seeking an experienced RDQA professional to support GCP/GVP audits, prepare audit materials, and ensure records are accurately entered into the Veeva Quality Vault system.

The role offers hybrid work options with potential for remote consideration based on qualifications; duration is 12 months with possible extension or conversion. Requires 4+ years in biotech/pharma and knowledge of GCP/GVP processes.

Qualifications

• BS/B.Sc in life sciences or STEM with 4+ years in biotech/pharma.
• Alternative: no degree with 6+ years of related experience.
• Experience with GCP or GVP processes for audits.

Responsibilities

• Maintain audit-related records across the program lifecycle.
• Compile data and documents for audits.
• Develop standardized templates based on regulatory requirements.
• Follow up with internal stakeholders regarding the RDQA audit program.
• Input and maintain audit reports in the Veeva Audit Module.
• Track and trend quality metrics for the RDQA program.

Skills

Veeva Quality Vault

Clinical Quality Auditing

GCP/GVP experience

Education

BS/B.Sc in life sciences or STEM

No formal degree with 6+ years experience

Tools

Microsoft Office

Job description

Quality Compliance Specialist – Onsite in Canada is seeking an experienced RDQA professional to support GCP/GVP audits, prepare audit materials, and ensure records are accurately entered into the Veeva Quality Vault system.

The role offers hybrid work options with potential for remote consideration based on qualifications; duration is 12 months with possible extension or conversion. Requires 4+ years in biotech/pharma and knowledge of GCP/GVP processes.