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 medicines. With capabilities from lab to patient, including a decentralized cell therapy manufacturing platform, we are committed to challenging the status quo and delivering results for our patients, employees, and shareholders. Our goal is not just to meet current medical needs but to anticipate and shape the future of healthcare, ensuring that our innovations reach those who need them most.
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 looking for a Director, Quality Risk Management.
Scope of the job
The QRM Leader will develop and implement the Quality Risk Management strategy at Galapagos, ensuring a compliant QRM framework and network across the organization. Key responsibilities include identifying and reporting Quality risks, conducting QRM assessments, and managing risk mitigation activities. The role involves routine collaboration with cross-functional teams to enhance and maintain QRM processes, while providing regular updates on the Quality risk profile to senior management. This global position may involve up to 30% travel, based on business needs.
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 Quality 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 e-System for Risk Management.
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 (as applicable)
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.
Support Quality staffing needs to hire or develop the appropriate level of capability, competencies to effectively carry out QRM responsibilities across the QMS framework.
Provide an inclusive work environment that ensures professional growth and development of cross functional team members through active training and development plans, and coaching.
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 training colleagues in 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 ?
At Galapagos, we prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead in pharmaceutical research and innovation.
We offer a competitive compensation package and a supportive work environment with strong focus on your health and well-being. Join us in our journey towards sustainability, as we strive to make a lasting impact on both the industry and the planet.
Galapagos is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.
We are Galapagos : together we can make it happen…!
Base compensation for this position ranges from $ 142,000 to $ 264,000. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job-related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time.
In addition, this position is eligible for participation in both Galapagos’ performance bonus plan and long-term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.
...HC-Resource is looking for highly skilled and driven Executive Sous Chefs . We have maintained a stellar reputation for providing quality food, superb beer selections and exemplary customer service excellence! Exciting New Concept ! We host a culinary-driven menu...
...nonprofit dedicated to empowering families is seeking a skilled Data & Reporting Manager to support the reporting and evaluation of... ...requirements clearly to diverse audiences. Proficiency in Microsoft Office Suite programs including Excel, Word, and PowerPoint. Formal...
...Armed Flex Field Security Officer | High-Profile Presence Required Location: Los Angeles, CA Why Join Phoenix Prime Security? We are not just offering a jobwe are presenting an opportunity to be part of an elite security force that sets the standard for high...
...Job Description Timmons Group is currently seeking a Licensed Surveyor to join our Survey Group located inour Wilmington, NC office location.The Licensed Surveyor is responsible for the successful management of assigned projects and for the management of...
We are looking for a Kindergarten English Teacher for an International Kindergarten based in Shanghais Songjiang district. This is... ...environment that is conducive to learning.Help children meet educational milestones through personalized instruction and assess each child...