CSV Audit 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), Spain (Madrid), Italy (Milano) and in US, Boston.
We’re 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: The ‘make-it-happeners’.
We are looking for a CSV Audit Lead (Associate Director)
Scope of the job
Galapagos has been discovering and developing drugs over the last twenty years and is now ready to go commercial. To support the growth of the company, we are looking to strengthen the Galapagos auditing team with an experienced CSV audit lead.
The incumbent will be responsible for defining the risk based audit strategy together with the Head of Global Audit and other key functions, creating and managing global CSV audit programs for GxP systems in scope, conducting/supervising audits End to End to ensure compliance with relevant regulation (GxP, 21CFR11, etc) and developing more junior auditors.
In this role, your principal accountabilities are to:
- Collaborate with the head of Global Audit, the Validation Team and business partners to develop the CSV risk based audit strategy.
- Create and maintain global CSV audit programs.
- Independently conduct Computer Systems Validation (CSV) audits in all GXPs areas to ensure that vendors, systems and internal processes are compliant with relevant CSV regulations and guidance.
- Manage audit activities (planning, execution and delivery) for less complex study and supplier audit activities, providing leadership and support to the auditors performing the audits.
- Provide CSV expertise (interpretation and guidance) to internal and external customers, proactively maintaining cognizance of current GxP standards and promoting a culture of quality.
- Undertake a variety of cross functional roles or assignments (lead or support) to further develop internal processes, acting as CSV expert.
- Actively support regulatory inspections for CSV related subjects, as requested.
- Develop more junior staff, as requested
Who are you ?
- You have a degree in Information Technology, Life Sciences, Pharmacy or Engineering; Advanced degree preferred.
- A minimum of 8 years of relevant experience in the Pharmaceutical Industry or another regulated industry and in particular in regulated functions such as Quality, Compliance and/or IT Security. Experience in auditing is required. Experience in other GxP areas (GVP/GMP/GCP/GLP) is a plus.
- Solid understanding and applications of global regulations and Health Authorities expectations governing computerized systems (CSV, 21CFR Part 11, WHO DI, etc.)
- Solid understanding of the development, implementation and lifecycle management of computerized systems in regulated environments.
- Experience in validation of Cloud, SaaS platform, mobile and digital application used in regulated environments is a plus
- Fluency in English (oral and written), additional language(s) a plus
- Successful cross-divisional/functional work with complex international teams
- Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude
- Ability to effectively interact and present to Management, health authority inspectors
- Passion for embedding quality within the organisation.
- The position may require approximately 15 % travel internationally.
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…!