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Head of Document Management/Head of Documentation

Ablynx

Ghent, Belgium

Purpose of the Position:

Head the quality department team responsible for the management of a variety of documents (including Quality, Scientific, Clinical and Training documents) and manage and perform a variety of tasks, including document organization, storage, providing access and creating templates in compliance with the GxP and R&D requirements.

Key Responsibilities:

  • You develop a strategy on how to structure Ablynx’ electronic and physical document system by creating an overall document management plan and ensure updates to fit with company evolving needs;
  • You determine together with relevant stakeholders the kinds of documents created or used by the organization and what template works best for each document type;
  • You ensure that documents required from a GxP and legal perspective are kept on hand or archived, but readily retrievable as needed;
  • You develop policies and procedures for the handling of the company's documents, whereby you develop systems to control and check access;
  • Special attention is given to the Controlled Quality Documents at Ablynx, whereby you ensure life cycle management, coding and periodic review;
  • You develop a training program related to document management and provide training upon request;
  • You support during inspections by external organizations and regulatory authorities.

Skills, Expertise and Contribution:

  • Able to develop and implement a strategy;
  • Good organizational and managerial skills;
  • Administrative consciousness and correctness;
  • Team player, good communication and negotiation skills, proactive;
  • Sense for initiative, quality, accuracy and detail;
  • Good writing/reading skills in English.

Minimum Qualifications:

  • Expected educational qualifications: at least a Bachelor degree;
  • Expected experience: 2-3 years experience in Document Management;
  • Very good knowledge of IT systems.

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