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.