Senior Specialist, Quality Control

The Quality Control department at Alvotech is looking for a dedicated and quality-minded senior specialist, with extensive experience in Analytical method technology transfers, CAPA management, Health Authority response, analytical investigations and scientific oversight. Scope and responsibility: Lead Analytical technology transfer activities between Alvotech and CMOs, ensuring successful method implementation and Lifecycle management of analytical methods. Act as the analytical subject matter expert for product testing methods, including chromatography, electrophoresis, compendial, and biochemical techniques. Coordinate transfer activities, troubleshoot technical challenges, and drive timely resolution of method-related issues. Author and Review transfer protocols, reports, validation undefined Author, review and approve CAPAs, change control, Document change controls, deviation investigation action and associated quality documentation. Lead and support investigations related to analytical quality events, including invalid assays, OOS, OOT, and OOE results. Lead the preparation of responses, scientific justifications for regulatory and Health Authority inquiries. Collaborate with ARD, Regulatory Affairs, Manufacturing, MSAT, and Quality Assurance teams to support product lifecycle management. Drive continuous improvement initiatives to enhance laboratory compliance, efficiency, and effectiveness. Ensure activities comply with cGMP requirements, internal procedures, and regulatory expectations. Perform training of other scientists in Analytical methods and related activities. Creates and updates documents for analytical methods Job requirements: Bachelor’s or master’s degree in technical discipline, (e.g., pharmacy, biotechnology, biochemistry, or a related field) 5-10 years of experience in Pharmaceutical or Biopharmaceutical industry. Proven experience in analytical method technology transfer and product lifecycle management. Strong experience in managing CAPAs, Change Controls, Deviations, and complex analytical investigations. Experience supporting regulatory submissions and responding to Health Authority queries. Expert knowledge within field of expertise such as methods, techniques as well as relevant procedural/process knowledge Open to flexible working hours. Excellent written and verbal communication skills.