Senior GCP QA Specialist: Audits, Inspections & Systems

Alvotech; Göteborgs kommun; On-site; SEK 900,000 - 1,300,000; Full time

Benefits offered by this job

Well-being benefits

On-site changing rooms

Snacks and coffee

Job summary

Alvotech in Göteborg seeks an experienced GCP quality professional to contribute to the development and excellence of the GCP-related segment of the corporate quality system. You will represent CMQ in study team meetings and coordinate audits for assigned trials, ensuring readiness for inspections and maintaining high data integrity.

You will conduct quality evaluations of providers, manage CAPA processes with clinical teams, and support deployment of computerized systems like Veeva Vaults

Qualifications

• BSc or MSc in pharmacology / pharmacy or life sciences.
• Minimum 5 years in GCP-operational or quality roles and GCP audits in multinational trials.
• Exposure to GCP inspections by FDA, EU, PMDA or MHRA.
• Experience with noncompliance from sites or providers.
• Strong digital skills with Veeva, eTMF, EDC, CTMS; AI/ML is a plus.
• Fluent English and at least one other official European language.

Responsibilities

• Contributes to development and excellence of the GCP-related segment of the quality system.
• Represents CMQ in study team meetings and with service providers for assigned trials.
• May conduct or coordinate GCP audits as assigned.
• Conducts quality evaluations of providers for GCP services and computerized systems.
• Coordinates GCP inspection readiness activities and supports inspection teams.
• Reviews essential records and ensures timely evaluation of data integrity.
• Reports significant deficiencies to CMQ, supports CAPA investigations with trial teams.
• Ensures follow-up of CAPAs from audits and inspections.
• Participates in deployment of computerized systems in clinical trials and manages records in Veeva Vaults.
• Conducts GCP training for internal staff as needed.

Skills

GCP quality management

Auditing

Communication

English proficiency

Additional European language

Digital acumen

Education

BSc or MSc pharmacology/pharmacy/life sciences

Tools

Veeva Clinical

Veeva Quality Vaults

AI/ML familiarity

eTMF/EDC/CTMS

Job description

Alvotech in Göteborg seeks an experienced GCP quality professional to contribute to the development and excellence of the GCP-related segment of the corporate quality system. You will represent CMQ in study team meetings and coordinate audits for assigned trials, ensuring readiness for inspections and maintaining high data integrity.

You will conduct quality evaluations of providers, manage CAPA processes with clinical teams, and support deployment of computerized systems like Veeva Vaults