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