Senior Product Complaint Specialist

We are looking for a Senior Product Complaint Specialist who will be responsible for leading investigations related to Product Quality Complaints (PQC), while also supporting deviation, OOS, and other quality event investigations in a GMP-regulated pharmaceutical environment. The role ensures investigations are conducted in a timely, compliant, and scientifically sound manner, identifying root causes and driving effective corrective and preventive actions (CAPAs), reporting to QA Investigations Manager.

Key Responsibilities

• Lead, conduct and document Product Quality Complaint investigations from initiation through closure.

• Perform root cause analysis using structured investigation tools and methodologies.

• Assess product impact and support risk evaluations.

• Develop, implement, and track CAPAs to completion.

• Collaborate with Manufacturing, Suppliers, Quality Control, Engineering, Supply Chain, and other functions to gather information and drive investigation outcomes.

• Ensure investigations are completed in accordance with GMP requirements, company procedures, and established timelines.

• Identify and recommend continuous improvement opportunities within the Quality Management System.

Qualifications & Experience

• Bachelor's degree in scientific discipline such as Chemistry, Microbiology, Pharmacy, Biochemistry, Engineering, or a related field.

• Minimum 3 years of investigation experience within a GMP pharmaceutical or biotechnology environment.

• Experience conducting Product Quality Complaint, deviation, OOS, and CAPA investigations.

• Strong understanding of cGMPs, quality systems, and regulatory expectations.

• Proficiency in root cause analysis and risk assessment methodologies.

• Excellent written communication, analytical, and problem-solving skills.

• Ability to manage multiple investigations and work effectively in a cross-functional environment.

What we offer:

• An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
• The chance to be a part of a global and fast-growing company.
• An international work culture that encourages diversity, collaboration, and inclusion.
• Positive, flexible, and innovative work environment.
• Support for personal growth and internal career development.
• Company social events and milestone celebrations.
• Excellent in-house canteen and coffee house.
• Exercise and well-being support for full-time employees.
• On-site shower facility.
• Transportation grant towards eco-friendly modes of travel for full-time employees.
• Internet at home for full-time employees.

About Us

At Alvotech, we are building a global biotechnology company with a clear purpose: to expand access to high-quality, affordable biologic medicines for patients worldwide. Our people are central to that mission. Across our global teams, we bring together expertise in science, manufacturing, quality and commercial operations to shape the future of biosimilars.

We offer a dynamic, fast-moving environment where curiosity, initiative and ownership are encouraged. Rooted in Icelandic values and operating on a global stage, we value collaboration, diversity and integrity across everything we do. Our teams work on meaningful challenges, contribute directly to patient impact, and grow alongside the business.

Whether you are at the start of your career or looking to take your next step, Alvotech offers the opportunity to do work that matters, in a company driven by purpose and scale.

If you do not see a role that matches your experience today, we still welcome general applications from individuals who share our ambition and want to help improve access to biologic medicines worldwide.

If you have any technical issues, please contact: [email protected]