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.
• 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.
• Certified Quality Auditor (CQA) – ASQ, or equivalent certification . • Experience auditing CMOs/CDMOs and complex supply chains. • Background with data integrity, CS V , 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).