SENIOR QUALITY ASSURANCE ASSOCIATE – GMP/GDP AUDITING (SAN DIEGO OR REMOTE)

Responsibilities

• Conduct risk-based GMP and GDP audits of contract manufacturers, testing laboratories, distribution providers, logistics partners, and/or medical device manufacturers.
• Plan, execute, and document on-site, remote, and hybrid interna/external audits.
• Assess compliance with applicable FDA, EU, ICH, ISO, and other regulatory requirements.
• Prepare audit reports, observations, and risk assessments.
• Review supplier responses and evaluate corrective and preventive action (CAPA) plans.
• Track audit findings and quality actions through closure.
• Communicate significant audit findings and compliance risks to Quality leadership and relevant cross-functional stakeholders.

Supplier Qualification & Oversight

• Perform supplier qualification, requalification assessments and risk-based recommendations.
• Review supplier documentation, inspection histories, quality metrics, and compliance records.
• Maintain supplier qualification records, risk assessments, and Approved Supplier Lists (ASLs).
• Monitor supplier performance, quality events, change notifications and assess their potential impact on product quality, patient safety, and regulatory compliance.
• Escalate significant quality or compliance risks as appropriate.

Quality Systems & Compliance

• Support GxP inspection readiness activities.
• Utilize electronic Quality Management Systems (e.g., Veeva Vault Quality Suite) to manage quality events and actions.
• Support the development, revision, and maintenance of quality procedures, work instructions, and related documentation.
• Participate in regulatory inspections, partner audits, and due diligence activities.

Continuous Improvement

• Contribute to quality system enhancements and process improvement initiatives.
• Support departmental and cross-functional quality objectives.
• Perform additional duties as assigned.