Sr Associate, Quality Assurance at Alnylam Pharmaceuticals in Cambridge, Massachusetts

Job Description:

Sr Associate, Quality Assurance

Department: Quality Systems

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 two 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 1,400 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 five years in a row (2015-2019), a Great Place to Work in the U.K. and Switzerland in 2020 and Science Magazine's #1 Top Employer in 2019. Please visit www.alnylam.com for more information.

Summary of Key Responsibilities

• Support the Global Quality Systems team with the QMS program elements, including, but not limited to:
  
  
  • Exceptions Management
  • Change Controls
  • Complaints and Post Marketing Processes
  • Document Control and Training
  
  
• Generate reports and calculate metrics from electronic systems
• Author and revise SOPs to meet the business needs
• Partner with functional areas to ensure timely closure of quality records and training completions
• Perform gap assessments of QMS processes against country regulations, make recommendations on alignment and track regional requirements
• Prepare internal presentations for various Quality communications
• Support the team with project management activities (i.e., follow-up with stakeholders, maintain templates, tools, and meeting minutes, create presentations, participate in process mapping activities)
• Maintain quality controlled records storage
• Support regulatory inspections as needed
• May participate on cross functional teams as QA representative

• Qualifications and Competencies
• BS in a related field with 2-4yrs experience
• Fundamental understanding of scientific principles, and general understanding of GMP, Quality, and the pharmaceutical processes.
• Actively advances 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 with all levels of the organization.
• Builds relationships among quality team members and has strong collaboration skills.
• Demonstrates ownership of activities within defined scope.