Head of Global Quality Risk Management - Basel,CH/Mechelen,BE/Remote
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 Head of Global Quality Risk Management - Basel,CH/Mechelen,BE/Remote
Scope of the job
As Head of Global Quality Risk Management, you will:
- Report to the Head of DS&T/RM/DI and provide input on budget and human resources planning
- Be accountable for implementing a quality Risk Management framework throughout the organisation for product and E2E quality risks
- Be accountable for the design, management and optimization of the quality Risk Management framework for product and E2E quality related processes within Galapagos
- Lead and develop Quality staff on RM process
- Lead the Development and maintenance of standardized templates and IT tools for quality Risk Management and write procedural documents and training packages to roll out the quality Risk Management framework to the wider organization
- Lead- together with a multifunctional team of SMEs the risk management activities
- Provide leadership /Own the Quality Risk Management Governance at Galapagos to ensure that Regulatory, Quality and Compliance and Galapagos’ requirements are met
- Provides strategic direction in identifying risks and opportunities, understanding the strategic and operational needs of the business
- Providing advice to relevant departments to incorporate any process changes in relation to changes in legislation and keeping up with future changes in legislation
- Providing support, education and training to departments to embed the Risk Management principles in the relevant part of the organisation
- Provide strategic leadership to the team to establish sound KPIs and metrics to ensure efficiency of processes
More in detail, you will:
- Lead Quality Risk Management initiatives in the company and assist in conducting Quality Risk Management assessments, developing remediation plans and strategies, and managing tasks to completion in collaboration of all function heads
- Provide Quality Risk Management guidance/expertise and ensure the Systems/ processes, implementation and change management are conducted in compliance with applicable regulatory requirements and industry quality Risk Management standards
- Create/Maintain the Quality Risk Management policies and procedures
- Set up and secure a compliant Quality Risk Management framework and Network
- Act as SPOC for Quality Risk Management during audits and inspections
- Engage and educate the relevant stakeholders to ensure sustainability
- 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 Quality Risk Management related GxP 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
Who are you?
- Advanced degree and proven industry experience (at least least 15 yrs) from Pharma, Biotech, Healthcare or Engineering background and experience working with GxP (GLP, GCP, GMP).
- Profound knowledge and understanding of the relevant regulations (e.g. 21 CFR Part 820 and European regulations/standards -ICH Q9 + Q10 or ISO 31000. ISO9001 familiarity with 21 CFR Part 11)
- Deep knowledge and understanding of of drug development process and the Global Regulatory Requirements
- Experience working within Quality Systems and prior experience managing/overseeing quality Risk Management
- Experience with quality Risk Management tools
- Forward thinking and the ability to create and apply sound quality Risk Management principles in innovation areas such as AI (or some other way of capturing the future ways of working)
- Experience in setting up and managing teams of QA professionals
- A diplomat and strong communicator, you reach goals by motivating and persuading others and as such facilitate decision-making within the company
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…!