Quality Assurance/ Data Integrity SME

Position Summary

The Quality Assurance (QA) / Data Integrity SME is responsible for ensuring compliance with GMP regulations, data integrity requirements, and company quality standards. This role supports audits, investigations, CAPAs, and regulatory inspections while serving as a subject matter expert on data integrity (paper and electronic based) and FDA 21 CFR Part 11 requirements.

Key Responsibilities

• Ensure compliance with GMP, data integrity, and regulatory requirements.
• Conduct and support internal, supplier, and regulatory audits.
• Serve as an auditor or audit observer during inspections and assessments.
• Investigate quality issues, deviations, and data integrity concerns.
• Develop, present, and track Corrective and Preventive Actions (CAPAs) through closure.
• Perform root cause analyses and recommend effective solutions.
• Review electronic records and audit trails for compliance.
• Support inspection readiness and regulatory interactions.
• Provide training and guidance on quality systems and data integrity principles.
• Prepare and deliver presentations on audit findings, CAPAs, and compliance activities.

Qualifications

• Bachelor's degree in a scientific, technical, or related field.
• 3+ years of Quality Assurance and Compliance in a regulated industry.
• 1+ years of Data Integrity experience in a regulated industry.
• Experience as an auditor and/or audit observer.
• Proven experience leading investigations and CAPA resolution.
• Strong presentation, communication, and problem-solving skills.

Required Knowledge

• FDA 21 CFR Part 11 (Electronic Records and Electronic Signatures).
• Data Integrity principles (ALCOA/ALCOA+).
• GMP regulations and Quality Management Systems (QMS).
• CAPA, deviations, change controls, and risk assessments.
• Audit trail review and computerized system compliance.

Preferred

• ASQ Certified Quality Auditor (CQA) or similar certification.
• Experience with systems such as TrackWise, Veeva, LIMS, Empower, SAP, or other validated GxP systems.
• Experience supporting FDA or other regulatory inspections.

Ideal Candidate

A QA professional with strong auditing experience, data integrity expertise, knowledge of FDA 21 CFR Part 11, and a proven ability to lead investigations, present CAPAs, and drive compliance improvements.