Associate III, Quality Technical Product Complaints

About This Role

As a Specialist in Product Complaints, you will play a critical role in ensuring the timely and compliant processing of product complaints and associated sample evaluations across Biogen’s global markets. You will support the complaint intake process, coordinate sample receipt and evaluation activities, and help drive investigations that support product quality and patient safety. Working closely with cross‑functional teams, you will analyze complaint data, identify trends, and contribute to continuous improvement initiatives within the Quality organization.

This role serves as a key link between affiliates, laboratories, and quality stakeholders to ensure consistent complaint handling and regulatory compliance.

• Respond to complaint‑related inquiries and manage team email correspondence.
• Process incoming product complaint cases and sample ship‑kit requests.
• Coordinate complaint sample shipments, receipt, storage, and laboratory evaluations.
• Analyze complaint data, identify trends, and communicate findings to management and stakeholders.
• Review and approve customer inputs for accuracy, consistency, and compliance.
• Conduct complaint investigations using structured investigative methodologies and root‑cause analysis tools to determine complaint cause and product impact.
• Support the development, maintenance, and execution of sample investigation methods.
• Evaluate complaint samples and document results in accordance with cGMP requirements.
• Assess complaint criticality and risk, identify appropriate escalation pathways, and determine next steps based on available evidence and quality requirements.
• Collaborate with Manufacturing, Quality Assurance, Quality Control, Engineering, Regulatory Affairs, Medical Safety, and Supply Chain partners to support investigations and resolution activities.
• Write and revise SOPs concerning the Technical Product Complaint Quality System with minimal guidance.
• Track, verify, and support implementation of corrective and preventive actions (CAPAs).
• Support laboratory safety, training, and equipment readiness activities.
• Manage multiple priorities and projects simultaneously while ensuring timely completion of deliverables.

• Detail‑oriented quality professional with a passion for product quality and patient safety.
• Excellent critical‑thinking skills with the ability to assess issue criticality and determine appropriate next steps.
• Strong written and verbal communication abilities.
• Experience supporting or conducting investigations, including root‑cause analysis and problem‑solving activities, within a cGMP environment.
• Proficiency in managing multiple priorities, projects, and deadlines in a fast‑paced environment.
• Strong cross‑functional collaboration and stakeholder management skills.
• Basic knowledge of Product Complaint systems/operations and cGMP requirements for biologics, oral‑dose products, medical devices, drug delivery devices, and combination products.
• Experience handling deviations, investigations, CAPAs, and effectiveness verification activities.
• Familiarity with risk management principles and risk‑based decision making.
• Experience leading or participating in cross‑functional improvement initiatives or projects.
• Working knowledge of quality tools such as 5
  
  Whys, Fishbone Analysis, Fault Tree Analysis, trending, and statistical analysis methods.

Base salary: $73,000.00 – $95,000.00 (annual). Additional short‑term and long‑term incentives may be offered based on performance.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E‑Verify Employer in the United States.