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Veeva Systems is seeking a Clinical Compliance Operations Specialist to manage GCP (Good Clinical Practice) project implementation audits and ensure internal adherence to regulatory processes. This role is responsible for defining, implementing, and maintaining quality processes across multiple product and service lines in regulated domains including GCP, HIPAA, and CSV (Computer Systems Validation).
Key responsibilities include verifying compliance with applicable policies, procedures, and regulations in GCP project implementations; performing GxP/Quality reviews of project deliverables and records; documenting audit findings and supporting remediation efforts; authoring GCP compliance records such as project audit reports; conducting process improvement activities and incident/CAPA (Corrective and Preventive Action) investigations; providing quality oversight on regulated activities including process definition, validation testing, and product releases; and performing supplier assessments to ensure compliance with regulated industry standards.
The ideal candidate holds a Bachelor's degree and has 3+ years of Clinical QA experience in Life Sciences with demonstrated expertise in Quality Management Systems, including documentation, record management, computer system validation, and investigation/CAPA programs. Strong working knowledge of ISO 9001, QSRs, and GCP regulations is essential, along with proven technical writing skills. The role requires comfort in a fast-paced environment with minimal direction, excellent written and oral communication, and strong decision-making and time management abilities.
Nice-to-have qualifications include experience with Veeva Development Cloud Clinical Data applications, clinical trials IT systems auditing, clinical system implementation, Agile methodology and SDLC understanding, computer systems validation expertise, and quality auditor certifications (ASQ CQA or ISO 13485 Auditing Certificate).
Veeva is a public benefit corporation and Work Anywhere company, supporting flexibility to work from home or in office. The company is a pioneer in industry cloud for life sciences, surpassing $3B in revenue with a mission to help bring therapies to patients faster.
