Alvotech

Medical Director

• Develop and continuously improve the GCP quality oversight and audit architecture enabling risk-proportionate CMQ supervision of clinical studies
• Ensure timely execution of the GCP audit program and quality evaluations of GCP service providers; may act as Lead Auditor for assigned audits
• Lead modernization and data analytics initiatives in CMQ to deploy solutions enabling quality innovation
• Define and own the inspectional intelligence framework for clinical study activities, including signal detection, trend analytics, and insight-to-action workflows
• Contribute to risk-management activities for GCP processes, computerized systems, and studies
• Coordinate with function and study leads on ongoing GCP inspection preparedness, coordination, and follow-up
• Act as QA approver of audit reports, serious noncompliance investigations, high-risk CAPA, and selected procedural documents
• Act as CMQ lead on one or more complex studies
• Represent CMQ on internal and external governance boards
• Lead a team of CMQ managers

Explore Director, Clinical Quality Evaluation and Inspection Intelligence at Alvotech. Review requirements and application details.

Director, Clinical Quality Evaluation and Inspection Intelligence

Compliance

• Prepare, review, and submit post-approval CMC regulatory filings, including Type IA/IB/II variations, PAS, CBE-30, CBE-0 supplements, annual reports, and renewals
• Ensure submissions meet regional requirements of the FDA, EMA, and other global health authorities
• Track submission timelines and ensure on-time delivery
• Evaluate CMC changes involving manufacturing, analytical methods, raw materials, and other areas for regulatory impact
• Support regulatory classification and filing strategy for change controls
• Collaborate with cross-functional teams to ensure appropriate documentation
• Maintain and update Module 3 CMC sections of regulatory dossiers
• Support lifecycle activities including CMC-related label updates, site transfers, and process improvements
• Ensure existing licenses comply with updated regulatory requirements
• Support preparation of responses to queries, deficiency letters, and information requests
• Assist in compiling documentation for regulatory inspections and audits
• Collaborate with Quality, Manufacturing, Supply Chain, and Technical Operations teams
• Participate in change control meetings and provide regulatory input
• Communicate regulatory requirements clearly to stakeholders

Explore Manager, Regulatory LCM CMC at Alvotech. Review requirements and application details.

Manager, Regulatory LCM CMC

Operations

• Execute and monitor the daily and weekly manufacturing supply plan for Drug Substance, Drug Product, and Finished Packed Goods
• Track production, inventory, material movements, agreed timelines, and quantities across internal sites and external CDMOs/CMOs
• Maintain accurate visibility of supply status and provide regular updates against the manufacturing plan
• Serve as the central contact for supply-related questions from internal and external stakeholders
• Update delivery dates in SAP and process order changes
• Track backorders, support prioritization, and coordinate bottleneck resolution
• Collect and consolidate data for supply chain KPI tracking, including OTIF, backlog, backorder levels, lead time, MOQ adherence, and ADS
• Prepare regular reports and dashboards
• Participate in demand control meetings and operational reviews with tactical planners
• Identify delivery risks and delays, escalating supply issues with supporting information
• Coordinate with Supply Chain Planning, Manufacturing, Quality, and Logistics teams
• Maintain SAP data for production orders, deliveries, and inventory
• Support month-end supply reconciliation activities

Explore SC Operations Specialist at Alvotech. Review requirements and application details.

Open roles

Director, Clinical Quality Evaluation and Inspection Intelligence

Manager, Regulatory LCM CMC

SC Operations Specialist