Associate Director, EU Quality Head and QP

Location: Netherlands

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Noord-Holland Netherlands.

The Company

They are leading the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to transform the lives of people with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system diseases with unmet need.

Role Description

This role will report to the Quality Head of the CEMEA region and act as the Quality Head for Europe and as a Qualified Person of the site in Amsterdam. The incumbent will lead operational QA activities and be responsible for building and maintaining the Quality team and Quality Management System for Europe, supporting affiliates and maintaining GMP/GDP licenses. This role will also be responsible for managing third party contract organizations and service providers within the region to ensure a successful supply of products to the market.

Responsibilities

- Build and lead the Quality team for Europe;
- Perform batch release and certification of drug products for the European market;
- Manage operational QA activities including internal/external audits and regulatory agency inspections for Alnylam Netherlands;
- Provide Quality support to European affiliates including inspection management, maintenance of an adequate Quality Management System and management of intra-company Quality Agreements;
- Manage product complaints, quality issues and recalls for Europe;
- Perform internal and external audits;
- Implement, monitor and report Quality KPIs for Europe;
- Manage third parties (manufacturing/packaging facilities, logistic service providers) located in Europe including qualification, auditing, product transfer, qualification/validation and contract management activities;
- Lead local continuous process excellence and improvement activities for Europe;

Requirements

- BS, Masters or Ph.D. preferably in life sciences (e.g. Pharmacy, Biology or Chemistry);
- Approx. 10 years Pharmaceutical industry experience in Quality and possibly manufacturing and/or Supply Chain related roles.
- Strong understanding of Pharmaceutical and Biologics cGMP/cGDP processes and regulatory requirements in the Netherlands and Europe;
- Proven track record with establishing and maintaining a Pharmaceutical Quality System;
- Experience with managing third party contractors and service providers;
- Experience as a GMP and GDP lead auditor;
- Ability to drive and manage issues, complaints, CAPAs and changes through to satisfactory conclusion;
- Proven track record with building and leading a Quality team;

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.