Quality Compliance Associate I/II

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. 

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).