About the role
Job Responsibilities-
- Plans, conducts, documents, and reports GCP audits in accordance with applicable regulatory requirements, ICH GCP, company procedures, and approved audit plans.
- Conducts investigator site, vendor, process, Trial Master File (TMF), internal, and computerized system audits.
- Evaluates clinical trial activities and computerized systems for compliance with applicable regulatory requirements, quality standards, and approved procedures.
- Performs and documents reviews of software validation activities and deliverables to confirm alignment with approved requirements, applicable procedures, intended use, and risk-based validation principles.
- Drafts and maintains software validation documentation, including validation plans, risk assessments, and validation summary reports.
- Reviews supporting validation documentation, including user requirements, test protocols and scripts, traceability documentation, deviations, and objective evidence.
- Assesses computerized system controls related to electronic records and signatures, data integrity, user access, audit trails, backup and recovery, data migration, and system lifecycle management.
- Owns validation change control activities, including assessment of proposed changes, determination of validation impact, documentation of required actions, and verification of completion before closure.
- Plans, conducts, and documents periodic system validation checks to confirm that computerized systems remain in a validated state throughout the system lifecycle.
- Evaluates compliance with applicable computerized system requirements, including FDA 21 CFR Part 11 and EU Annex 11, as applicable.
- Identifies, documents, and communicates audit observations and compliance risks and reviews related Corrective and Preventive Action (CAPA) responses through closure.
- Supports sponsor audits and regulatory inspections by providing GCP auditing and computerized system validation expertise.
- Maintains audit documentation, reports, trackers, and supporting quality records in accordance with company procedures.
- Collaborates with functional areas to address audit observations, compliance risks, and quality improvement opportunities.
- Performs other Quality Assurance duties as assigned.
Additional Responsibilities-
- Provides guidance and training related to GCP auditing, computerized system validation, data integrity, and regulatory compliance.
- Supports quality risk assessments associated with new or modified computerized systems used in clinical research.
- Provides QA oversight and validation support for system implementation, upgrades, migrations, and retirement activities, as appropriate.
- Supports client interactions related to audits, GCP compliance, and computerized system validation.
Education-
- Bachelor's degree in Life Sciences, Computer Science, Information Technology, Engineering, Quality, or a related field; advanced degree preferred.
- Minimum of 5 years of experience in the pharmaceutical, biotechnology, medical device, or CRO industry, including experience in Quality Assurance, GCP auditing, computer system validation, or a combination of these areas.
- Demonstrated experience conducting GCP audits in a regulated clinical research environment.
- Demonstrated experience performing documented software validation reviews and drafting validation plans, risk assessments, and validation summary reports.
- Experience owning validation change controls and conducting periodic system validation checks. Experience supporting sponsor audits and regulatory inspections preferred.