Director, Global Quality Management System

Company: Federation of American Societies for Experimental
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Director, Global Quality Management System - TOQA2020R1013

AP Director, Global Quality Management System - TOQA2020R1013 Alnylam Pharmaceuticals

Cambridge, Massachusetts, United States

4 days ago

Description

Director, Global Quality Management System

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.

Reporting to the Head of Global Quality Quality Systems & CEMEA (Canada, Europe, Middle East and Africa) Quality, the Director of Global QMS will oversee the company’s Global Quality Management System program including Regulatory Agency inspections.

Responsibilities

Expand and improve the global Quality Management System in support of clinical and commercial activities related to medicinal products and devices/combination products

Ensure compliance with applicable Global Regulatory requirements, guidelines

Lead management of global Quality Metrics

Lead and improve the global G x P Training program

Manage Quality issues, Product Complaints and Recalls at global level

Support enterprise-wide capability build initiatives , including the implementation and improvement of IT-System workflows and the provision of user support

Collaborate with all Quality Expertise Areas in preparing the organization for Regulatory Inspections

Host Regulatory Agency routine and Pre-Approval Inspections in the US

Requirements

Qualifications

At a professional level, we are seeking an individual with a minimum of ten years of experience in a Quality Assurance leadership role within the biotechnology or pharmaceutical industry. Ideally, this individual will have succeeded in establishing and maintaining a global Quality Management System in a highly reputable company that has transition ed from Phase III clinical trials into commercial production. The following is a list of professional requirements for the role:

Bachelor of Science in Chemistry, Biology, Chemical Engineering, or related Life Sciences

Advanced degree, Master’s or Ph.D., in similar fields is highly desired

Extensive knowledge of cGM P s and device/combination product regulations, additional knowledge of GDP, GCP and GVP requirements desired

Demonstrated success in hiring and staffing a growing organization as well as mentoring high potential individuals

Experience establishing in-house Quality policies, standards , SOPs and associated training programs

Extensive experience in preparing and hosting Regulatory Inspections

An established network of relationships within the industry

At a personal level, the successful candidate must demonstrate the following qualities and characteristics:

Sense of urgency; ability to recognize time sensitivity and lead aggressively

Flexible and adaptable style with an eagerness to take on challenges

Visionary as well as tactile and concrete at an operational level

Problem solver/trouble shooter who not only identifies issues but leads efforts to resolve them

A “roll-up-your-sleeves” and “get involved” attitude

Strong leadership and motivational capabilities

Ability to work as a true team player and be effective in a collaborative culture

Responsive and “quick-on-their-feet” when experiencing changes

Complex thinker who has the ability to articulate options for ambiguous situations, but ultimately has the confidence to make decisions with authority and with the full understanding of the potential down-stream consequences

Highly skilled in building strong relationships at global, cross-functional level

Excellent communication skills, both oral and written

Proven ability to present efficiently to senior management

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

#LI-CF1

Job Information

Job ID: 54481729

Location:

Cambridge, Massachusetts, United States

Position Title: Director, Global Quality Management System - TOQA2020R1013

Company Name: Alnylam Pharmaceuticals

Job Function: Management

Job Type: Full-Time

Job Duration: Indefinite

Min Education: BA/BS/Undergraduate

Min Experience: Over 10 Years

Required Travel: None

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Keywords: Federation of American Societies for Experimental , Cambridge , Director, Global Quality Management System, Other , Cambridge, Massachusetts