QA Compliance Lead Auditor (Host)

Key Responsibilities:

• Coordinate and host business development, sponsor qualification, routine sponsor audits, regulatory inspections, and for-cause audit activities, including scheduling, agendas, request lists, SME coordination, and preparation of audit/inspection support materials.
• Serve as a primary point of contact for external auditors, sponsors, inspectors, internal stakeholders, and operational teams throughout the audit or inspection lifecycle. 
• Support operational team readiness before, during, and after external audits and inspections, including preparation meetings, document collection, interview coordination, and issue escalation. 
• Facilitate audit and inspection activities as host, support, or coordinator, ensuring requested documentation, systems access, and subject matter experts are available in accordance with applicable procedures. 
• Manage receipt, triage, review, and internal routing of external audit reports, including coordination of stakeholder review, finding assessment, response ownership, and timelines. 
• Review and challenge external audit responses, corrective actions, and CAPAs to ensure they are adequate, complete, clearly supported, aligned with procedural expectations, and responsive to the reported observations. 
• Track external audit commitments, responses, CAPAs, evidence, and follow-up actions to support timely completion, closure, and appropriate escalation of overdue or quality-critical items. 
• Support regulatory inspection readiness and for-cause audit coordination by compiling requested information, maintaining audit/inspection records, and providing status updates to leadership and relevant stakeholders. 
• Assist with cross-training, mentoring, coaching, and/or supervision of auditors, audit hosts, or audit support staff as required. 
• Maintain professional and technical knowledge through continuing education, review of relevant guidance and publications, and participation in professional networks as appropriate; contribute to team objectives and perform other duties as assigned. 
• Contribute to the development and interpretation of global QA policies related to regulatory requirements.
• Conduct internal audits as directed, such as process/system and service provider quality assessment for qualification/requalification
• Perform other related duties as assigned.

Minimum Qualifications:

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Relevant and equivalent experience may be considered in lieu of formal education.
• Fluent in English, written and verbal.

Required Experience:

• Minimum 8 years of experience in a regulated environment, including GxP roles.
• Demonstrated regulatory expertise with detailed knowledge of GCP and applicable global regulations.
• Experienced Lead GCP Auditor with strong critical thinking and risk-based assessment skills.
• Strong strategic communication skills with clients and internal stakeholders.
• Experience leading or contributing to quality and process improvement initiatives reducing inspection risks and strengthen inspection readiness.

Preferred Qualifications Include:

• Postgraduate degree (MSc or equivalent) in a scientific or management‑related discipline.