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Salary: EUR 60,000 - 100,000 / annual
Veeva Systems is seeking a Clinical Compliance Operations Specialist to manage GCP (Good Clinical Practice) project implementation audits and ensure internal adherence to regulated processes. This role is critical to maintaining quality and compliance across Veeva's clinical product lines and service offerings.
You will facilitate GCP project implementation audits, verify compliance with applicable policies, procedures, and regulations, and ensure quality processes are defined and maintained across multiple product lines and regulated domains including GCP, HIPAA, and CSV (Computer Systems Validation). Working with cross-functional global teams, you'll provide GCP support for Veeva products across various service areas.
Key responsibilities include: verifying compliance to policies and regulations in GCP project implementations; performing GxP/Quality reviews of records and project implementation deliverables; documenting audit findings and supporting remediation efforts; authoring GxP documents and records to promote GCP compliance; performing process improvement activities and incident/CAPA (Corrective and Preventive Action) investigations; providing quality oversight on regulated activities such as process definition, validation testing, and product releases; and conducting supplier assessments to ensure compliance with regulated industry standards.
You'll work in a fast-paced environment with minimal direction, adjusting priorities as needed. The role requires strong technical writing skills, excellent communication abilities, and solid decision-making capabilities. You'll execute projects and duties as assigned to ensure compliance across Veeva's product line and internal business systems.
Veeva is a public benefit corporation and industry cloud pioneer in life sciences, having surpassed $3B in revenue. The company operates as a Work Anywhere organization, supporting flexibility to work from home or in the office.
