Quality Systems Specialist

QMS Specialist

• Somerville, MA

• Additional role available in Cambridge, MA

• Providing subject matter expertise to assure Quality System records meet global regulatory requirements and industry practices.
• Supporting the management and tracking of quality system records (i.e. Deviation, CAPAs, Effectiveness Checks and Change Controls) for adherence to organizational or departmental targets.
• Driving improvements and supporting changing regulations/requirements of our quality system content and processes.
• Supporting generation of quality system metrics and trending, and escalate issues as required.

Supporting training, usage, and ongoing configuration changes to the electronic QMS system and collection of metadata needed for existing documents in the Quality System, Veeva.
• Compiling analysis for and communicating upcoming/aging Quality System records to Record Owners.
• Participating in Inspection Readiness activities.

• BA/BS in a scientific discipline 4+ years of experience in a Quality Assurance/Quality Systems role.
• Veeva Quality System experience strongly preferred.
• Experience using validated electronic Quality Systems with an understanding of Part 11 compliance and strong knowledge of processes, requirements, and application in pharmaceutical industry.
• Knowledge of US and EU cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements.
• Excellent communication skills and ability to influence across multiple functions.