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.
What You’ll Do
- Respond to complaint-related inquiries and support team email management
- 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 utilizing 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 cross-functionally 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
Who You Are
You are a detail-oriented quality professional who is passionate about product quality and patient safety. You enjoy investigating complex issues, evaluating risk, solving problems, and collaborating across teams in a highly regulated environment. You can think critically through ambiguous situations, assess issue significance, identify appropriate actions, and drive investigations to effective conclusions. You are comfortable leading discussions, influencing stakeholders, and balancing compliance with business needs.
Required Skills
- Bachelor's Degree in Life Sciences, Engineering, Quality, or related discipline plus 2+ years of experience in a quality or product complaints cGMP environment
- Experience supporting or conducting investigations, including root cause analysis and problem-solving activities, including knowledge of investigative methodologies and quality system processes
- Strong critical thinking with the ability to assess issue criticality and determine appropriate next steps
- Demonstrated ability to manage multiple priorities, projects, and deadlines in a fast-paced environment
- Strong cross-functional collaboration and stakeholder management skills
- Strong written and verbal communication abilities
Preferred Skills
- Knowledge of Product Complaint systems/operations and cGMP requirements for biologics, oral-dose products, medical devices, drug delivery devices, and combination products
- Knowledge of Product Complaint regulations and standards (e.g., FDA, EMA, ISO 13485, ISO 14971)
- Medical device and/or combination product complaint handling experience
- Experience handling deviations, investigations, CAPAs, and effectiveness verification activities
- Experience 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
