Senior Director, Head of GxP Compliance and Quality Systems - Mechelen, BE; Leiden, NL or Basel, CH

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

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 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 Senior Director, Head of GxP Compliance and Quality Systems - Mechelen, BE; Leiden, NL or Basel, CH

Scope of the job

The Head of GxP Compliance and Quality Systems provides leadership and expertise to support development of innovative and high-quality products to patients in compliance with all GxPs.

Specifically, the Head of GxP Compliance and Quality Systems leads a team of Quality professionals in executing a corporate wide Quality Management System (QMS) focused on multiple areas including Global Compliance, Quality Systems, Data Integrity, Quality Risk Management, Document Control, GxP Training and Audit and Inspection.

It is expected the person in this role works routinely and effectively with their team members and business stakeholders to develop, execute and continuously improve the suitability, effectiveness of the QMS in order to ensure GxP compliance of the Galapagos business.

This global role requires approximately 25-50% travel, depending on home office location.

Your role

• Be a strategic driver for Quality Strategy Implementation, ensuring alignment between the Galapagos QMS, regulatory expectations and business & operational goals.
• Be a visible leader in building and sustaining a quality culture within the business.
• Staff and lead a team of Quality professionals with the appropriate level of capability and empowerment to effectively carry out the following responsibilities within Galapagos.
• Develop and maintain a quality system ensuring compliant, lean/pragmatic and user-friendly Quality Processes and related e-Systems that effectively support and manage the life cycle stages of a multi-modal portfolio of products, and which enable the ultimate goal of product commercialization.
• Ensure effective delivery and awareness of the quality system principles throughout Galapagos, and to the appropriate level in external partners.
• Collaborate with business partners and stakeholders to:
  • Understand and respond as needed to performance-related observations, emerging risks and upcoming changes
  • ensure their perspectives are included in driving continuous quality performance improvement and innovation.
• Serve as Executive business process owner for key Quality processes (e.g., Change Control, CAPA, auditing, etc.). Maintain Center(s) of Excellence around key processes.
• Maintain quality oversight within the business through an appropriate, effective and risk-based quality auditing program.
• Oversee adherence to data governance and data integrity principles throughout all the product life cycle, including Discovery, non-clinical and clinical development stages.
• Provide, manage and lead a management framework for Health authority inspections and audits by third parties. Support development and execution of CAPAs.
• Oversee Quality Risk Management program, using it to enable continuous quality improvement, and ensure awareness by Senior management of significant Quality risks.
• Maintain a process to continuously evaluate changes in the regulatory environment.
• Collaborate with internal and external stakeholders and partners to identify and implement best practices in Quality Innovation.
• 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 plus at least 12 years experience in biopharmaceutical quality. Strongly prefer experience with ATMPs and/or other biotechnology products.

Demonstrated experience in Quality management systems leadership.

Proficiency with applying ICH Quality Guidelines and GxPs in clinical and commercial environments.

Demonstrated experience in leading/managing health authority inspections.

Experienced with Quality risk management concepts (e.g., ICH Q9).

• Familiarity with product quality and regulatory filing documents and processes.
• Understand Business Development activities and needs from a Quality perspective.

• Strong people leader, capable of engaging, motivating and ensuring productivity in a team of Quality professionals.
• Collaborative and effective in working with team members, cross-functional colleagues, and external partners.
• Capable of providing Quality leadership across functions and organizational levels, and engaging/motivating a matrix team of professionals as needed.
• Demonstrated capability in developing and deploying business strategies.
• Able to lead change programs in a highly regulated environment, involving stakeholders at all levels across different companies, functions, and regions as needed.

• Capable of presenting complex issues and/or important topics in a manner that is easily understood cross-functionally and for 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.

We are Galapagos: together we can make it happen…!