Director, Digital Technology and Quality Engineering

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 a decentralized, point-of-care CAR-T manufacturing network, 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, Digital Technology and Quality Engineering

Scope of the role

The Digital Technology and Quality Engineering Director (DT&QE Director) is responsible for providing strategic, risk-based Quality Assurance guidance and oversight to planning and execution of computerized systems validation (CSV) and commissioning, qualification and validation (CQV) of GxP facilities, utilities and equipment throughout all Galapagos businesses and facilities. The DT&QE Director serves as a key advisor to ITS and other business partners for major strategic initiatives related to GxP computerized systems and related business processes. The DT&QE Director leverages business and regulatory intelligence in conjunction with collaborative working relationships maintained with Quality and non-Quality functional groups to support a cohesive corporate-wide network of tools, systems, equipment and processes.

Your role

• Ensure implementation of the global CSV quality strategy and all applicable Galapagos (GLPG) and regulatory requirements for all GxP regulated computerized systems.

• Establish trusted partnerships with ITS and/or business owners of systems, facilities, equipment and instruments by gaining thorough understanding of strategic roadmap, and collaborating effectively to ensure delivery of key projects within agreed timelines.

• Lead the DT&QE team to ensure appropriate resourcing, skills and processes are in place to deliver effective, risk-based Quality input and expertise to the planning and execution of strategic projects (including at 3 ^rd parties).

• Interface as key partner with ITS and business functions for CSV topics related to GxP classified computerized systems and GLPG business processes.

• Ensure life-cycle activities and documentation of the global/local GxP systems in scope of responsibility are planned for and appropriately supported (e.g., qualification and validation, periodic review, change control, decommissioning).

• Routinely assess risk areas related to scope of responsibilities, manage mitigation activities, and escalate significant compliance issues as needed to senior leadership.

• Ensure subject matter expertise (SME) is available and prepared for topics related to scope of responsibility for health authority inspections and quality audits, including preparation of related documents, and interaction within inspectors/auditors as SME.

• Lead or participate in audits or assessments of suppliers and service providers, especially those related to computerized systems and automation.

• Provide ownership / SME as appropriate to execute, review and/or approve investigations, CAPA, and change controls related to CSV and Data Integrity deviations and quality observations.

• Collaboratively support the Quality leadership team in goal-setting, development and execution of strategy, organization and budget planning, and priorities management.
  
  

Who are you?

• Degree in Information Technology, Life Sciences, Pharmacy or Engineering

• Minimum 10 years in pharmaceutical industry and/or quality assurance

• Minimum 6 years in CSV Quality role or related discipline (e.g., digital Quality)

• Minimum 3 years of people management

• Industry experience with cell therapy and biotechnology products is preferred

• Expert-level knowledge of regulatory requirements for computer systems validation, Data integrity, data governance, and control of electronic records and signatures.

• Proficient in the conduct of GxP/CSV related health authority inspections and audits

• Demonstrated experience in the technical architecture and application of computerized systems commonly used in the pharmaceutical/biotechnology industry

• Demonstrable experience in the development, implementation and lifecycle management of computerized systems including validation/qualification of Cloud, SaaS platform, mobile and digital application used in regulated environments

• Experienced with commissioning/qualification/validation of facilities, utilities, equipment and instruments.

• Experienced practitioner of Quality Risk Management

• Possess relevant GxP knowledge and understanding of drug development processes

• Proven ability to assimilate new and emerging compliance information or trends and translate into impact for GLPG

• Approximately 25% Travel should be expected

GENERAL SKILLS

• High level of business awareness alongside analytical, strategic-thinking, and problem-solving skills with a proven ability to understand business impact of GxP and CSV
• Demonstrated leadership skills across functions and organizational levels, with ability to engage and motivate a team of professionals.
• Proficiency with application of ICH Quality Guidelines, cGMP’s, CFR’s, EC/JP GMPs for cell therapies within the appropriate clinical or commercial environment
• Proven ability to influence and negotiate effective solutions through leading change and driving for results; adept at resolving conflict as necessary
• Communicates with clarity, impact and passion tailored to audience
• Effective in cross-divisional/functional work, including with complex international teams
• Experienced with project management and execution
• Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude
• Demonstrated ability to work both independently and in a team environment
• Fluency in written and spoken English mandatory. Multi-lingual is desirable
• Evidence of continuous professional development

What’s in it for you ?

You will be part of a fast growing and amazing company and member of the Business Development team. 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…!