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.
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
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.
Master's Degree or Bachelor's Degree in life sciences or equivalent plus 2+ years of experience in a qualitycGMP environment
Microsoft Office products
Cross-functional collaboration
Strong written and verbal communication abilities
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:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
