What are the responsibilities and job description for the Director, Quality Risk Management position at Galapagos?
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
Who are you ?
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.
Salary : $142,000 - $264,000
