Remote Clinical Compliance & QA Operations Specialist

Veeva Systems; Ireland; On-site; EUR 60,000 - 100,000; Full time

Job summary

Veeva Systems is seeking a Clinical Compliance Operations Specialist to lead and coordinate GCP project implementation audits, ensuring adherence to Veeva processes across multiple product and service lines and regulated domains such as GCP, HIPAA, and CSV.

You will work with global cross-functional teams to promote GCP compliance, author GxP documents, review deliverables, and support incident management and CAPA investigations while maintaining quality oversight in regulated activities.

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
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
• Excellent written and oral communication skills, good decision-making skills 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 supports 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

Technical writing

Written communication

Time management

Adaptability

Education

Bachelor’s degree or equivalent

Job description

Veeva Systems is seeking a Clinical Compliance Operations Specialist to lead and coordinate GCP project implementation audits, ensuring adherence to Veeva processes across multiple product and service lines and regulated domains such as GCP, HIPAA, and CSV.

You will work with global cross-functional teams to promote GCP compliance, author GxP documents, review deliverables, and support incident management and CAPA investigations while maintaining quality oversight in regulated activities.