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