Associate III, Quality Technical Product Complaints

Product Complaints Specialist

This position is hybrid to our Cambridge MA facility and require frequent on-site presence

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 quality c GMP 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

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

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…