GCP & Quality Compliance Operations Specialist

Veeva Systems, Inc.; San Francisco (CA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

Veeva Systems, Inc. seeks a Clinical Compliance Operations Specialist to manage GCP project implementation audits and ensure internal adherence to processes across product and service lines. The role collaborates with global teams to promote GCP compliance, author records, review deliverables, and assess suppliers.

The candidate will have a Bachelor's degree and 3+ years in clinical QA within Life Sciences, plus strong technical writing and communication skills for a fast-paced environment.

Qualifications

• Bachelor’s degree or equivalent relevant experience required.
• 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 ISO 9001 or QSRs, GCP regulations and guidelines.
• Proven technical writing skills.
• Excellent written and oral communication skills in a fast-paced environment.

Responsibilities

• Verify compliance to policies, procedures, work instructions and regulations in GCP project implementations.
• Perform GxP/Quality review of records including deliverables.
• Document audit findings and support remediation efforts to audit observations.
• Promote GCP compliance by authoring records (e.g., audit reports).
• Perform process improvements and incident/CAPA investigations.
• Provide quality oversight on regulated activities and deliverables for in-scope products and systems.
• Perform supplier assessments to ensure supplier capabilities for regulated industry.

Skills

Technical writing

Communication

Decision making

Education

Bachelor’s degree or equivalent relevant experience

Job description

Veeva Systems, Inc. seeks a Clinical Compliance Operations Specialist to manage GCP project implementation audits and ensure internal adherence to processes across product and service lines. The role collaborates with global teams to promote GCP compliance, author records, review deliverables, and assess suppliers.

The candidate will have a Bachelor's degree and 3+ years in clinical QA within Life Sciences, plus strong technical writing and communication skills for a fast-paced environment.