The Role
Supports GCP quality systems for international clinical trials, including audits, inspection readiness, service-provider evaluations, CAPA follow-up, essential-record reviews, temperature-excursion assessments, computerized-system deployment, Veeva Vault workflows, and GCP training. Requires substantial biopharmaceutical or CRO experience, regulatory inspection exposure, strong knowledge of global clinical-trial requirements, and expertise with Veeva and related clinical technologies.
Summary Generated by Built In
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.
- 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.
- 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.
Skills Required
- BSc or MSc in pharmacology, pharmacy, healthcare, or another relevant life-sciences field.
- At least 5 years of combined experience in GCP-governed operational or quality roles and GCP audit roles.
- Experience with multicentric international clinical trials in biopharmaceutical companies or CROs.
- Experience in oncology and immunology therapeutic areas.
- Demonstrated exposure to GCP inspections by FDA, EU authorities, PMDA, or MHRA.
- Experience managing significant noncompliance involving clinical investigator sites and GCP service providers.
- High digital acumen and experience with Veeva Clinical and Quality Vaults.
- Experience optimizing and integrating processes with digital applications.
- 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-trial regulatory requirements.
- Experience with other eTMF, EDC, and CTMS applications.
- Experience using AI and machine learning.
- Recognized GCP Auditor qualification, such as SQA RQAP-GCP or EFGCP.
- ACRP-CP, CCRA, or CCRC credentials.
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The Company
What We Do
Alvotech is a global biotechnology company focused exclusively on developing and manufacturing biosimilar medicines. Its mission is to improve patients’ lives by expanding access to affordable biologic treatments worldwide. The company operates as a fully integrated specialty biopharmaceutical business, pursuing high-quality biosimilars and building treatment options that can make important biologic therapies more accessible to patients through its research, development, and production capabilities.
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