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Skills: Quality, Product Complaints, Root Cause Analysis, Problem Solving, Critical Thinking
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Taunton, Massachusetts, United States · On-site
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Billerica, Massachusetts, United States · On-site
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Billerica, Massachusetts, United States · On-site
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Boston, Massachusetts, United States · On-site
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Boston, Massachusetts, United States · On-site
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Skills: Technical Program Management, NPI Execution, Hardware Development, Manufacturing Process Development, Risk Management
Cambridge, Massachusetts, United States • Hybrid
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As a Specialist in Product Complaints, you will ensure the timely and compliant processing of product complaints and associated sample evaluations. You will analyze complaint data, identify trends, and collaborate with cross-functional teams to support investigations and resolution activities.
A Bachelor's Degree in Life Sciences, Engineering, Quality, or a related discipline is required, along with 2+ years of experience in a quality or product complaints cGMP environment. Strong critical thinking, collaboration, and communication skills are essential for this role.
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 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
Additional Information
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:
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 Follow us on social media – LinkedIn, Instagram, Facebook, X, and YouTube.
Offices: 225 Binney Street, Cambridge, MA 02142, US · Landis & Gyr-Strasse 3, Zug, CH 6300, CH · P.O. Box 14627, 5000 Davis Drive, Research Triangle Park, NC 27709, US
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