Director, Quality Risk Management - any Galapagos location

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.

We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies and biologics in oncology and immunology. With capabilities from lab to patient, including Decentralized Manufacturing Unit(s) of CAR-T, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.

We pioneer for patients. 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-happener’.

We are expanding our US footprint to set-up our decentralized CAR-T network and further build our research capabilities in the US.

We are currently looking for a Director, Quality Risk Management - any Galapagos location

Scope of the role

The Quality Risk Management (QRM) Leader will lead the development and implementation of the Quality Risk Management strategy in Galapagos. This role will collaborate across the company to set-up and secure a compliant QRM framework and network.

The QRM Leader will provide a framework for detecting and reporting Quality risks in the business, conducting QRM assessments as needed, and managing risk mitigation activities. This includes mechanisms to routinely apprise Senior management of the Galapagos Quality risk profile.

It is expected the person in this role will work routinely and effectively with cross-functional partners and stakeholders in Galapagos to implement and continuously improve the QRM strategy and related processes in order to maintain a consistent level of understanding and process execution.

This global role requires up to 25% travel, depending on home office location.

Your role

• Provide leadership and own the QRM governance at Galapagos to ensure regulatory, quality and compliance is met. Be a visible leader in building and sustaining a QRM culture within the business and ensure processes for identifying and managing risks and opportunities align with the strategic and operational aspirations of the business.
• Implement and execute a QRM framework throughout the organization to enable detection of end-to-end quality risks. This includes QRM standards, Policies, SOPs, and templates.
• Effectively introduce the integrated QRM system to the wider Galapagos organization, including training/education in QRM principles and the Galapagos QRM processes.
• Establish a process for routine review of mitigation for existing risks with relevant stakeholders. Actively contribute to the routinely-scheduled management reviews to address the status of known risks and the associated mitigation plans.
• Lead or assist in conducting and managing QRM assessments when needed, including development and management of remediation plans.
• Establish meaningful KPI and metrics to ensure efficiency in the QRM process. Serve as business process owner for the QRM process and Veeva RM System.
• Collaborate with business partners and stakeholders to understand and respond as needed to emerging risks, including assessment of upcoming changes to products, processes or ways of working.
• Contribute to the applicable Pharmacovigilance System Master File (PSMF) sections as the QRM Leader.
• Support the Galapagos QMS in areas such as (but not limited to):
  • Mitigating risk within quality process effectiveness
  • establishing risk-based internal auditing schedule and program
  • establishing processes for supplier quality management and auditing
  • preparing for executing Health authority inspections and third party audits
  • continuously evaluating changes in the regulatory environment.
• Staff and lead an appropriately-sized team of QRM specialists with the appropriate level of capability and empowerment to effectively carry out the above responsibilities.
• Provide an inclusive work environment that ensures professional growth and development of team members through active training and development plans, coaching, and performance feedback processes (e.g., 1:1 meetings, skip-level meetings).

Who are you?

• Science degree preferred and at least 10-12 years’ experience in biopharmaceutical quality. Strong preference for experience with ATMPs and/or biotechnology products.

• Strong understanding and experience in application of QRM principles (e.g., ICH Q9) and other relevant industry GxP regulations and guidelines in a clinical environment.
• Demonstrated proficiency with using and teaching common QRM Tools (e.g., Risk assessments, Failure mode Effect Analysis, standards for measuring risk, etc.)

• Possesses capability to engage and motivate cross-function teams.
• Collaborative and effective in working with team members, and cross-functional colleagues to understand support needs and effectively impart technical information.

• Demonstrated ability to present complex issues and/or important topics in a manner that is easily understood cross-functionally and by all audiences within the organization.

• Experienced with decision making, and analytical problem solving, including proficiency with root cause analysis tools / methodologies.

• Capable of understanding and assimilating into a corporate structure and culture.

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…!