GCP Compliance & Quality Operations Specialist

Veeva Systems, Inc.; Greater London; Hybrid; GBP 65,000 - 90,000; Full time

Job summary

Veeva Systems, Inc. is seeking a Clinical Compliance Operations Specialist to drive GCP project audits and uphold quality processes across multi-line products and regulated domains.

The role collaborates with global teams to promote GCP compliance, author GxP documents, and manage incident remediation. The ideal candidate has 3+ years in Clinical QA within Life Sciences, strong technical writing, and a proven ability to navigate ISO 9001/QSRs, GCP guidelines, and CAPA programs in a fast-paced

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

GCP compliance

Quality auditing

Technical writing

Communication skills

Time management

Education

Bachelor’s degree

Tools

ISO 9001 / QSRs

CSV

Job description

Veeva Systems, Inc. is seeking a Clinical Compliance Operations Specialist to drive GCP project audits and uphold quality processes across multi-line products and regulated domains.

The role collaborates with global teams to promote GCP compliance, author GxP documents, and manage incident remediation. The ideal candidate has 3+ years in Clinical QA within Life Sciences, strong technical writing, and a proven ability to navigate ISO 9001/QSRs, GCP guidelines, and CAPA programs in a fast-paced