Sr. Manager, IT Validation & Compliance

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 IT Validation & Compliance Engineer is responsible to manage the validation implementation of IT systems and processes that will support the growth of Alnylam GxP capabilities, as well as lead validation maintenance activities for existing systems. The position requires CSV and validation program/strategy background in a regulated environment, and knowledge of applicable regulations and regulatory expectations.

Summary of Key Responsibilities

• Design & execute risk-based strategy for Alnylam CSV lifecycle.
• Represent IT in close collaboration with Quality Assurance and internal business partners to determine validation requirements.
• Lead development of validation plans.
• Write & execute validation protocols and other deliverables.
• Assist with development of written procedures supporting the validated system lifecycle.
• Ensure adherence to validation maintenance requirements, such as system periodic review.
• Participate in support of SOX audits and regulatory inspections.
• Position has potential for management of contract staff assigned to CSV projects.

• Minimum of a Bachelors degree is required. Science, engineering, or IT-related field is preferred.
• A minimum of 5 years working in a regulated environment, with a minimum of 2-3 years experience in validation-related activities.
• Demonstrated ownership of assigned CSV activities, including quality of deliverables and project timelines.
• Local travel between sites may be required.