Principal Specialist, Clinical Quality Assurance

Scope and responsibility: - Contributes to development and excellence of the GCP-related segment of Alvotech corporate quality system. - Represents CMQ in study team meetings, and in meetings with service providers for the assigned clinical programs / trials - May conduct or coordinate GCP audits, as assigned. - Conducts quality evaluations of service providers for GCP services and computerized systems - Coordinates GCP-inspection readiness activities, and represents a key member in inspection coordination teams. - Reviews select set of essential records - Ensures timely evaluation of temperature excursions for IMP reported from clinical sites - Reports significant quality deficiencies to CMQ management, supports investigations and development of CAPA with clinical study teams - Ensures follow-up of CAPAs derived from audits, inspections and reported deviations. - Participates in operational deployment of computerized systems in clinical trials. - Manages records and workflows in Veeva Vaults. - Conducts GCP training to internal staff, as needed. Job requirements: - BSc or MSc in pharmacology / pharmacy, healthcare or other relevant life sciences. - Minimum 5 years of combined experience in GCP-governed operational or quality roles and GCP audit roles in multi-centric international clinical trials in biopharmaceutical companies or in CRO; including in the following therapeutic areas: oncology, immunology. - Demonstrated exposure to GCP inspections by FDA, EU authorities, PMDA or MHRA; - Experience in managing significant noncompliance stemming from clinical investigator sites, and GCP service providers. - High digital acumen and experience with Veeva Clinical and Quality Vaults, optimization and integration of processes with digital applications; experience in utilization of AI/ML highly preferred. Experience with other eTMF, EDC, and CTMS applications, highly desired. - Excellent communication, writing, and presentation skills in English and at least one other official European language. - Strong understanding of EMA, US-FDA and other national clinical trials-governing regulatory requirements. - Preferably, a holder of GCP Auditor qualification evidence / credentials issued by an internationally recognized organization, e.g. SQA RQAP-GCP, EFGCP, etc. ACRP-CP, or CCRA/CCRC credentials. What we offer: - Meaningful Work: Tackle inspiring challenges with passionate colleagues on projects that make a real difference in people’s lives. - Global Growth: Join a fast-growing, international company with a diverse and inclusive culture. - Collaborative Environment: Work in a positive, flexible, and innovative setting that values teamwork and creativity. - Career Development: Benefit from support for personal growth, internal mobility, and ongoing training opportunities. - Cultural Exchange: Take advantage of exchange opportunities with our Reykjavik, Iceland lab for short or long-term stays. - Well-being & Perks: Enjoy wellness benefits, on-site changing rooms, and a stocked office with snacks, fruit, and great coffee. - Community & Celebration: Participate in regular social events and celebrate team milestones together. Originally posted on Himalayas