Job Description:

Overview

Alnylam is the world's leading RNA interference (RNAi) company.

Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with three approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development.

Headquartered in Cambridge, Mass., Alnylam employs over 1,500 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work six years in a row (2015-2020), a Great Place to Work in the U.K. and Switzerland two years in a row (2019-2020) and a Science Magazine's Top Employer two years in a row (2019-2020). Please visit www.alnylam.com for more information.

The Quality Assurance Specialist will report to the Sr. Manager of Global Quality Management Systems and is responsible for the maintenance and continuous improvement of the Global Quality Management System (QMS) at Alnylam. Additionally, this position is responsible for providing quality and compliance guidance and support on interpretation of GxP regulations, quality system requirements, corporate standards and policies for alignment with existing FDA and other health agency regulations and ensure compliance of the QMS global processes.

Key Responsibilities

• Support the Global Quality Systems team with the QMS elements, including but not limited to:
  
  
  • Deviations
  • CAPAs
  • Change Control
  • Metrics/KPIs
  • QMS Enhancements
  
  
• Support the generation of QMS metrics for KPIs, prepare reports and internal presentations for management review
• Perform gap assessments of QMS processes against country regulations in order to make
• Provide recommendations on alignment and harmonization of shared processes
• Develop procedures and work instructions to meet business and compliance needs
• Build cross functional teams to monitor the health and compliance of the Quality System
• Partner with key stakeholders to improve upon system processes and reporting capabilities in the QMS/eQMS
• Provide training and support to new users in Veeva eQMS
• Mentor Global QMS Partners to ensure consistency of use and of messaging of the Quality

System

• Lead and facilitate various global Quality Systems enhancement and implementation projects.

Qualifications

• BS in a related field with 4 ‐ 6yrs experience
• Fundamental understanding of scientific principles, and general understanding of GMP, Quality,

and the pharmaceutical processes.

• Advanced GMP and Quality knowledge base.
• Adapts well to change and transitions smoothly to new responsibilities.
• Demonstrates problem solving ability (within and outside of comfort zone) and attention to detail.
• Complete assigned tasks as directed with limited oversight.
• Ability to complete assignments in an accurate, timely, and clearly documented manner.
• Understanding of project goals and ability to make limited decisions autonomously.
• Ability to identify and escalate issues appropriately.
• Effective, open and direct communication skills through the organization.
• Builds relationships among quality team members and has strong collaboration skills.
• Demonstrates ownership of activities within defined scope.

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

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