Manufacturing Compliance Specialist

About the role

Alvotech is looking for a detail‑oriented Manufacturing Compliance Specialist to support quality operations in biomanufacturing. You will ensure adherence to cGMP standards, drive continuous improvement, and help maintain a compliant production environment.

Key responsibilities

• Initiate and investigate deviations reported in manufacturing.
• Own handling of deviations (non‑process, system/facility, utility), CAPAs, change controls and change actions.
• Trend deviations, develop metrics for batch records and turnaround time, and identify improvement areas.
• Review facility risk assessments, EMI deviations and trend reports.
• Provide compliance oversight during biomanufacturing runs across Grade A, B, C and CNC areas.
• Troubleshoot, review and approve quality documents, including planned changes.
• Track on‑time closure of quality records and monitor KPI compliance.
• Perform monthly EHS inspections and support GMP record reviews.
• Conduct routine facility walkthroughs to ensure inspection readiness.
• Assist with regular audits and interactions with regulatory agencies.

Required profile

• Degree/Diploma in a related discipline or equivalent experience.
• Minimum 3 years of compliance experience in biomanufacturing.
• Experience supporting Pre‑Approval Inspections and working with FDA, EMA or other regulatory bodies.
• Knowledge of DP operations is a plus.

Required skills

• cGMP compliance
• Deviation handling and investigation
• CAPA management
• Change control processes
• Batch record metrics and reporting
• Risk assessment and EMI deviation analysis
• EHS inspection procedures
• Regulatory guidelines (FDA, ICH, PIC/s)
• Audit support and regulatory agency interaction

What we offer

• Opportunity to work on ambitious projects that impact patients' lives.
• Collaborative international work culture.
• Growth within a fast‑expanding global biotech company.