Data Integrity Lead - Mechelen,BE
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville & Paris), the Netherlands (Leiden), Switzerland (Basel), Italy (Milano), Spain (Madrid), the UK (London), Germany (München), and in the US (Boston).
We are in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you.
We are looking for a Data Integrity Lead – Mechelen, BE
Scope of the job
As a Data Integrity Lead, you play a key role in the design and management of data integrity and data governance at Galapagos. In this position, you will take ownership of the Records Life Cycle management process and of the Data Integrity Compliance to ensure that Regulatory and Galapagos’ requirements are met. Thinking steps ahead, identifying risks and opportunities, understanding the strategic and operational needs of the business, keeping up to date with regulations and managing vendor relationships, are among the challenges generating your enthusiasm for this opportunity. The role reports to the Head Quality Management.
More in detail, you will:
- Manage Data Integrity initiatives in the company and assist in conducting data integrity gap assessments, developing remediation plans and strategies, and managing tasks to completion;
- Provide DI guidance and ensure that the systems/process implementations across GxP operations are conducted in compliance with applicable regulatory requirements and industry data integrity standards;
- Design/maintain the Data Integrity policies and procedures;
- Set up and secure a compliant Records (Retention) Management Process, Record Retention Schedule and a framework of Central- and Departmental record coordinators;
- Act as SPOC for the Data Integrity and Record Management Process during audits and inspections and offer guidance for Interim archive process filing;
- Engage and train the relevant stakeholders to ensure sustainability;
- Liaise between the off-site archive vendor and internal record coordinators. Manage and oversee the archiving vendor including the vendor qualification and maintain oversight of GxP records archived at off-site facility;
- Organize clean-out activities upon endorsement by management;
- Keep oversight on process of retrieval and re-archiving of GLPG records, based upon an appropriately approved document request;
- Appropriate destruction of records at end of their lifecycle, after proper approval and in line with effective RRS;
- Advocate and exhibit the quality mind-set and behaviours, which will enable effective adherence to our standards;
- Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of GMP policies and quality management system, including providing guidance and direction for transitioning from clinical to commercial phase GMP operations;
- Benchmark within and outside of the Company, including regulatory agencies, business partners and suppliers.
- Master/Bachelor in Scientific related Studies with 5 years of relevant working experience
- You are able to keep oversight whilst performing or supervising diverse activities for multiple projects, good planning and organizing skills describe you as a professional!
- A diplomat and strong communicator, you reach goals by motivating and persuading others and as such you have impact on and you facilitate decision-making within the company
- You have a profound knowledge and understanding of the relevant regulations
- Your professionalism goes hand in hand with pragmatism when you ensure a sustainable implementation of regulations
- You have a good business understanding and an excellent command of English
What’s in it for you?
You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos : together we can make it happen…!