Principal Specialist Bioanalytical Study Quality

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About the Department/Company

Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high-quality biosimilar medicines.

Within Research and Development (R&D) function, the integrated Clinical and Medical Research (iCMR) department develops effective strategies aligned with biosimilar guidelines and health authority requirements to deliver successful clinical studies, and support post marketing-authorization related activities.

iCMR is launching an ambitious and exciting project aimed at modernizing and optimizing the departmental operating model. As part of this project, we are recruiting for the following position:

Overview of Job Role

This role primarily serves as a direct quality partner with relevant subject matter experts in iCMR to ensure integration of quality advisory and quality oversight in bioanalytics of human samples derived from clinical trials. Reporting to Clinical and Medical Quality (CMQ) within Alvotech corporate quality unit, the incumbent will be responsible for deploying of risk-proportionate quality assurance and oversight tactics on assigned clinical programs/trials, as well as in other strategic initiatives in remit of CMQ, as relevant to innovation in iCMR and CMQ.

Scope and responsibility:

• Act as a primary GCLP quality liaison for assigned clinical programs / trials in clinical team meetings.

• Conduct quality evaluation / audit of select internal and external records and reports stemming from bioanalytical method validations and clinical samples analyses.

• QA approve select records stemming from qualification, calibration, or validations, as applicable, of laboratory premisses, key instruments and computerized systems.

• Conduct quality evaluation of service providers.

• Advise in complex noncompliance investigations.

• Conduct quality approval of reported lab investigations and deviations.

• Contribute to risk management activities.

• Administer the CMQ-owned GCLP segment of Alvotech corporate quality system.

• Contribute to inspection and audits coordination and follow-up activities.

• Approve CAPAs, effectiveness check and objective evidence.

• Manage CMQ-owned documents and records in Veeva.

Job requirements:

• BSc/University degree in biochemistry, molecular biology, or other relevant life sciences focused in instrumental analytics

• Minimum 4 years of combined experience in GCLP-governed operational and quality assurance roles in biopharmaceutical companies or service providers, in instrumental analysis of human biological material obtained in clinical trials.

• Experience in quality oversight of GCLP laboratories, service providers, and laboratory computer systems.

• Experience in auditing of laboratory plans, records, and reports, pertaining to validation, qualification / calibration and sample analysis.

• Minimum 2 years of exposure to GCP / BIMO inspections conducted by FDA or EU Member states authorities (PMDA / MHRA / ANVISA inspection experience desired)

• High digital acumen and experience in working with Veeva Quality Vault and variety of LIMS systems.

• Excellent communication, writing, and presentation skills in English.

• Advanced understanding of applicable ICH, ISO and EU regulations governing analytics in clinical trials; understanding of principles of pharmacokinetics and immunogenicity.

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.