Clinical Compliance Operations Specialist

About the role

Veeva is seeking a Clinical Compliance Operations Specialist to ensure GCP project implementations adhere to internal processes and regulatory standards across multiple product lines. The role works with global cross‑functional teams to promote compliance, author GxP documentation, and support quality oversight.

Key responsibilities

• Verify compliance with policies, procedures, work instructions, and GCP regulations during project implementations.
• Perform GxP/Quality reviews of project deliverables and document audit findings.
• Author audit reports and other GCP compliance records.
• Lead process improvement activities, incident investigations, and CAPA actions.
• Provide quality oversight for regulated activities, including validation testing and product releases.
• Conduct supplier assessments to ensure capabilities meet regulated industry requirements.

Required profile

• Bachelor’s degree or equivalent experience.
• 3+ years in a Clinical QA role within life sciences.
• Experience with Quality Management Systems, documentation, computer system validation, investigations, and CAPA programs.
• Working knowledge of ISO 9001, GCP regulations, and related quality principles.
• Strong technical writing and communication skills.
• Ability to thrive in a fast‑paced environment with minimal direction.

Required skills

• Quality Management Systems (QMS)
• ISO 9001 quality standards
• Good Clinical Practice (GCP) regulations
• Technical writing
• Veeva Development Cloud (Clinical Data) Applications
• Agile methodology
• Software Development Life Cycle (SDLC)
• Computer Systems Validation (CSV)