Senior Manager, GxP Audit Program Lead

Position Overview
The Audit Program Lead owns the execution and continuous improvement of clinical site, vendor qualification, and internal audit programs.

Responsibilities
- Ensure execution of a risk-based audit program (master/annual schedules, qualification methodology, requalification cadence) across clinical site, supplier/vendor, and internal audit domains.
- Lead end-to-end execution of clinical site and vendor audits: risk-based site selection, planning, agenda development, on-site/remote oversight, report finalization, response resolution, and CAPA completion.
- Tailor audit scope/depth using GxP requirements and compliance risk factors; perform initial review of audit reports, observations, and responses.
- Maintain a current qualified vendor list; track Quality Agreement status and revisions.
- Lead end-to-end internal audits of process compliance: manage logistics, track findings to resolution, and guide SMEs through root cause analysis and CAPA development.
- Interpret and apply global regulations/guidance to assess organizational compliance.
- Support inspection readiness and regulatory agency inspections as part of the Quality Inspection team; represent the audit program as an SME.
- Manage contract auditors to ensure quality, consistency, and regulatory rigor; manage auditor and external auditee relationships to resolve scheduling and ensure scope/observation alignment.
- Process CDAs/contracts/POs/invoices for contract auditors and verify auditor qualifications prior to engagement.
- Track and trend observations to identify risks/systemic gaps; communicate to Quality leadership.
- Collaborate with QA to adjust audit priorities/scope; own audit program metrics/reporting.
- Continuously refine audit processes, tools, and templates; ensure audit records are maintained in QMS (Veeva, Egnyte GxP) and audit-ready at all times.
- Review compliance documents, SOPs, and protocols as assigned.

Qualifications
- BS in life sciences or related field.
- 8+ years biotech/pharma experience including 5+ years in Quality Assurance; significant hands-on audit coordination/execution, specifically clinical site auditing.
- Ability to work autonomously, manage competing priorities, and drive execution with minimal oversight.
- Auditor certification (e.g., ASQ CQA, RAB, or equivalent) preferred.
- Deep practical understanding of GxP audits, including vendor/site risk assessment, risk-based qualification, and audit responses.
- Working knowledge of vendor qualification and internal auditing processes.
- Extensive knowledge of global GMP/GCP (FDA, EU, ICH) and best practices.
- Strong written/verbal communication and stakeholder influence.
- Exceptional organization/detail; manage multiple concurrent audits.
- Critical thinking and pragmatic problem-solving.
- Up to 10% travel.

Preferred Qualifications
- Additional quality/auditing certifications; experience training/mentoring/managing auditors.
- Experience hosting/supporting regulatory agency inspections.
- Experience leading quality process improvement initiatives.
- Proficiency with Veeva or similar compliance/QMS software.