Principal Specialist, Clinical Quality Assurance

About this role

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.