QA Validation Manager

Dicerna – Cambridge, MA

The Sr. Quality Assurance Manager / Associate Directors main responsibility is to provide Quality oversight of facilities, equipment, processes, cleaning, and method validations in a cGMP environment performed for Dicerna at Contract Manufacturing Organizations/Contract Testing Labs. Internal Dicerna validation systems may include computer systems validation oversight. The position will review and approve validation documentation, batch records and change controls, as well as provide input for GMP validation activities against regulatory requirements. Additional responsibilities may include conducting internal/external audits and training. This position provides quality recommendations and guidance to project teams and manages other compliance duties as assigned.

These May Include:
  • General - Contributes to defining and timely achievement of overall project goals. Provides compliant solutions to a variety of problems of moderate scope and complexity. Interacts constructively with employees; managers and cross-functional peers. May lead a project with a limited scope; but usually a contributor on broader projects. Provides guidance to other Professionals and Technicians.
  • Risk Management - Applies basic Risk Management principles to work. Participates in the development or modification of Risk management files.
  • Design Control / Documentation & Change Control - Identifies areas for process improvement. Provides supporting information for change including reasons and justifications.
  • Quality Engineering - Coordinates quality decisions between different quality and engineering groups. Participates in the development or modification of validation packages; design plans; and risk management deliverables (e.g. FMEAs). Team member helping and interfacing with suppliers to deliver product meeting our quality requirements
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