Associate III, Product Complaints

Job Description

Individual contributor role providing direct support in Biogen Technical Product Complaint function as it pertains to product-related consumer complaints, ensuring compliance with regulatory standards for the markets in which the company’s products are manufactured or distributed.

• Processes incoming Technical Product Complaint cases. Coordinates and compiles case investigations ensuring global consistency and compliance.
• Independently handles and evaluates Technical Product Complaint sample returns as per procedure. Coordinates further evaluations with contractors and vendors.
• Manages investigation of high criticality cases aligning with relevant groups to identify root case and corrective action.
• Manages internal or external lab under management supervision and ensure processes comply to SOP/ GMP.
• Writes, reviews, and evaluates SOPs concerning the Technical Product Complaint Quality System with minimal guidance.
• Leads inter department collaboration with development teams (software, device and packaging) to best support new product introduction and implement an effective feedback system.
• Identifies Product Complaint system gaps or quality initiatives. Leads improvement teams/initiatives at global level to address issues and resolutions. Drives implementation with some to full autonomy.
• Generates routine and ad hoc global metrics of Technical Product Complaint Quality System data. Ability to analyze and interpret data for trends and deduce root cause(s).
• Initiates, cultivates and maintains business relationships with other internal departments as well as external vendors and contractors.
• Engage with partner with stakeholder groups including Patient Services, Safety, External manufacturing, Technical Development and IT on continuous improvements, investigations and trouble shooting.

Qualifications

• Knowledge of TPC systems/operations and cGMP requirements for biologics, oral-dose, medical devices, drug delivery devices and combination products
• Possess keen interpersonal skills, and the ability to work in a team environment
• Possess strong verbal and written communication skills with the ability to make presentations routinely
• Education:Bachelor or Master’s Degree within Life Sciences or Engineering with2-5 years of industry experience or equivalent. Preferable to have prior experience in Product Complaint, Product Development (software, device and packaging) or Customer Relations functions. Experience working within the Healthcare Industry, ideally within the Quality or Technical Product Complaint functions

Additional Information

This individual, as part of our Quality organization, will have responsibility for product related customer complaints, ensuring compliance with regulatory standards for the markets in which the company's product are manufactured and distributed. You may also lead project teams when needed and should initiate and implement changes and improvements with support from management.