Key Responsibilities
Plan, execute, and report on internal audits of GxP processes (e.g., GMP manufacturing, QC, validation, laboratories, supply chain).
Lead or support supplier/vendor audits and monitor ongoing supplier performance.
Prepare detailed audit agendas, checklists, and sampling strategies aligned with risk and compliance priorities.
Document findings clearly; issue audit reports with classifications, evidence, and actionable recommendations.
Track and verify effectiveness of CAPAs (Corrective and Preventive Actions) and drive timely closure.
Support inspection readiness activities and host/liaise during regulatory inspections (e.g., FDA, EMA, MHRA).
Perform gap assessments against current regulations and industry standards; propose reasonable improvements.
Collaborate with QA/QC, Manufacturing, Regulatory, Supply Chain, and IT to strengthen quality systems.
Maintain audit schedules, metrics, and dashboards; communicate status to stakeholders and management.
Contribute to policy/SOP development, training, and continuous improvement initiatives.
Minimum Qualifications
Bachelor's degree in a scientific or technical field (e.g., Chemistry, Biology, Engineering) or equivalent experience.
1-2 years of auditing experience within biopharma, biotech, medical devices, or related regulated industry.
Working knowledge of FDA 21 CFR Parts 210/211, ICH Q-series, EU GMP, and GDP principles.
Experience performing audits against quality system elements (Deviation, CAPA, Change Control, Training, Document Control).
Strong technical writing skills and attention to detail; able to produce clear, evidence-based audit reports.
Proficiency with risk-based auditing, root cause analysis, and CAPA effectiveness verification.
Excellent communication and stakeholder management skills; comfortable engaging at all levels.
Preferred Qualifications
Certified Quality Auditor (CQA) – ASQ, or equivalent certification.
Experience auditing CMOs/CDMOs and complex supply chains.
Background with data integrity, CSV, Annex 11, and Part 11 assessments.
Exposure to biologics, cell & gene therapy, aseptic processing, or sterile manufacturing.
Knowledge of ISO 9001/13485, 21 CFR 210/211, and pharmacovigilance quality systems (as applicable).