This position is hybrid to our Cambridge MA facility and require frequent on-site presence
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. Coordinates and conducts risk-based case investigations ensuring due diligence, global consistency and compliance
Evaluate complaint samples and document results in accordance with GMP requirements
Support development, maintenance, and execution of sample investigation methods
Coordinate complaint sample shipments, receipt, storage, and laboratory evaluations
Manage complaint intake activities and sample ship-kit requests
Review and approve customer inputs for accuracy, consistency, and compliance
Conduct complaint investigations and support root cause analysis activities
Write and revise SOPs concerning the TPC Quality System with minimal guidance
Track and verify corrective and preventive actions (CAPA)
Analyze complaint data and identify trends across products and affiliates
Drive continuous improvement initiatives within complaint management processes
Support laboratory safety, training, and equipment readiness activities
Who You Are
You are a detail-oriented quality professional who is passionate about product quality and patient safety. You enjoy investigating issues, analyzing data, collaborating across teams, and improving processes in a regulated environment.
Required Skills
Master's Degree or Bachelor's Degree in life sciences or equivalent plus 2+ years of experience in a quality cGMP environment
Microsoft Office products
Cross-functional collaboration
Strong written and verbal communication abilities
Preferred Skills
Knowledge of Product Complaint systems/operations and cGMP requirements for biologics, oral-dose, medical devices, drug delivery devices and combination products
Knowledgeable in Product Complaint regulations (e.g., FDA, EMA, ISO). Medical device and/or combination devices experience
Experience handling deviations and CAPAs
Job Level: Professional
Additional Information
The base compensation range for this role is: $73,000.00-$95,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
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.
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities.
We apply deep understanding of human biology and leverage different modalities, to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
With approximately 7,000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Baar, Switzerland and we have world-class manufacturing facilities in North Carolina and Solothurn, Switzerland. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
For more information, please visit www.biogen.com. Community Guidelines: https://www.biogen.com/community-guidelines.html
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