Remote GxP Compliance Operations Lead

Veeva Systems, Inc.; Dublin; Hybrid; EUR 60,000 - 100,000; Full time

Job summary

Veeva Systems is seeking a Clinical Compliance Operations Specialist to manage GCP project implementation audits, ensuring internal adherence to Veeva processes and maintaining quality across product lines and regulated domains.

The role partners with global cross-functional teams to promote GCP compliance, author GxP documents, review deliverables, conduct CAPA investigations, and support supplier assessments in a fast-paced environment. Experience with ISO 9001, QSRs, and CSV is valued.

Qualifications

• Bachelor’s degree or equivalent relevant experience.
• 3+ years in a Clinical QA role in Life Sciences.
• Experience with Quality Management Systems (e.g., documentation and record management, computer system validation, investigations, CAPA programs)
• Working knowledge of Quality Principles as manifest in ISO 9001 or QSRs, GCP regulations and guidelines
• Proven technical writing skills
• Excellent written and oral communication, good decision-making and time management skills

Responsibilities

• Verify compliance to applicable policies, procedures, work instructions and regulations in GCP project implementations
• Perform GxP/Quality review of various records, including project implementation deliverables
• Document audit findings and support remediation efforts to project audit observations
• Promote GCP compliance by authoring records (e.g., project audit reports)
• Perform process improvement activities and incident/CAPA investigations
• Provide quality oversight on regulated activities and deliverables, such as process definition, validation testing, and product releases/changes for in scope products and systems
• Perform supplier assessments to ensure supplier capabilities providing products and services to a regulated industry
• Execute other projects/duties as assigned to ensure compliance across Veeva’s product line and internal business systems

Skills

Quality Management Systems

GCP regulations

Technical writing

Communication skills

Time management

Decision-making

Education

Bachelor’s degree or equivalent

Job description

Veeva Systems is seeking a Clinical Compliance Operations Specialist to manage GCP project implementation audits, ensuring internal adherence to Veeva processes and maintaining quality across product lines and regulated domains.

The role partners with global cross-functional teams to promote GCP compliance, author GxP documents, review deliverables, conduct CAPA investigations, and support supplier assessments in a fast-paced environment. Experience with ISO 9001, QSRs, and CSV is valued.