QA Compliance Lead Auditor – Host

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee and facilitate business development, sponsor qualification, routine sponsor audits, regulatory inspections, and for-cause audit activities.

• Arrange audits and inspections, create agendas and request lists, coordinate Subject Matter Experts (SMEs), and prepare supporting materials.

• Act as the main point of contact for external auditors, sponsors, inspectors, internal stakeholders, and operational teams throughout the audit or inspection process.

• Assist operational teams in preparation for external audits and inspections before, during, and after the events.

• Organize preparation meetings, gather documents, coordinate interviews, and escalate issues as necessary.

• Facilitate audit and inspection activities in the capacity of host, support, or coordinator.

• Ensure that all requested documentation, systems access, and subject matter experts are available in accordance with applicable procedures.

• Manage the receipt, triage, review, and internal routing of external audit reports.

• Coordinate stakeholder reviews, assessment of findings, ownership of responses, and adherence to timelines.

• Review and critically assess external audit responses, corrective actions, and Corrective and Preventive Actions (CAPAs).

• Monitor audit commitments, responses, CAPAs, evidence, and follow-up actions until completion and closure.

• Support readiness for regulatory inspections and coordination of for-cause audits.

• Compile requested information, maintain records of audits and inspections, and provide status updates to leadership and stakeholders.

• Assist in cross-training, mentoring, coaching, and/or supervising auditors, audit hosts, or audit support staff.

• Keep professional and technical knowledge current through ongoing education, relevant guidance and publications, and professional networks.

• Contribute to the development and interpretation of global Quality Assurance (QA) policies related to regulatory requirements.

• Support team objectives and undertake other related tasks as assigned.

• Serve as backup for QA Management and assist with operational reporting responsibilities.

• Lead the reporting of quality metrics and engage in continuous improvement initiatives across the QA organization.

⛳️ Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.

• Relevant and equivalent experience may be accepted in place of formal education.

• Proficient in English, both written and spoken.

• At least 8 years of experience within a regulated environment, including roles in GxP.

• In-depth knowledge of Good Clinical Practice (GCP) and applicable global regulations.

• Proven experience as a Lead GCP Auditor.

• Strong critical thinking and risk-based assessment capabilities.

• Excellent strategic communication skills with clients and internal stakeholders.

• Experience in leading or contributing to quality and process improvement initiatives that reduce inspection risks and enhance inspection readiness.

• A postgraduate degree (MSc or equivalent) in a scientific or management-related discipline is preferred.

• Must have the legal right to work in the US without requiring employer-sponsored work permits.

• This position is not eligible for sponsorship.

• Ability to utilize a variety of computer software, both custom-developed and off-the-shelf applications.

• Capability to lift and carry items, including luggage and a laptop computer, with a maximum weight of 15–20 lbs.

• Regular and consistent attendance is required.

• Varied working hours may be necessary.

🏝️ Benefits

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Life insurance.

• Short-term disability (STD).

• Long-term disability (LTD).

• 401(K) plan.

• Flexible time off (FTO).

• Comprehensive benefits for eligible regular full-time or part-time employees working 20 or more hours per week.