Quality Management Lead GCP

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 looking for a Quality Management Lead GCP.

Scope of the job

The QML GCP is the point of contact for the Clinical Development teamsfor all quality topics, with focus on GCP compliance.

The Quality Management Lead GCP isresponsible for implementing the "pro-active quality principles"throughout the Clinical Development organization by providing continuoussupport and input during the Clinical Development Activities in the GCP area.

Your role:

• Quality point of contact (POC) for Clinical Development, Central Quality Teams and in the appropriate governance bodies
• Build GCP compliance awareness throughout the Clinical Development organization:
  • Build and maintain strong cross-functional collaborative working relationships. Assist in driving change to build a culture of quality compliance throughout the Clinical Development organization.
  • Provide continuous quality compliance support by acting as an internal advisor on relevant processes, procedural documents and regulations to ensure correct interpretation and implementation.
  • Ensure operational support and quality oversight for quality processes as e.g. CAPA, audits, inspections, deviation management, risk management, change control, quality complaint handling, etc.
  • Identify, manage and mitigate quality compliance risks, in collaboration with the operational and central Quality teams
  • Act as a point of contact for any quality related questions, concerns
  • Escalate quality / compliance / privacy issues and support investigation
  • Drive Quality Management Review (QMR) Level 1 meetings
• Ensure through intense collaboration with the Quality Management System (QMS) team that the QMS is fit for the specific business, tailored where possible and standardized where needed:
  • Act as quality ambassador and advocate for QM process changes and implementation
  • Contribute to the creation of new procedural documents, as well as to the revision of procedural documents
  • Conduct procedural documents review and approval activities
  • Identify the impacts of changing regulations across the GxP areas

• Participate in and collaborate to continuous improvement initiatives.
• Support in training activities i.e. process training, new regulations training, new systems training
• Enable compliance and implementation of the quality processes
• Collaborate to audit and inspection activities:
  • Collaborate with the audit team giving input for the creation and maintenance of audit programs
  • Assist the business stakeholders to ensure proper CAPA formulation and timely CAPA implementation and follow-up
  • Conduct, reporting and follow-up of vendor QA qualification assessments
  • Contribute to Regulatory Authority Inspections
  • Identify areas for improvement based on Quality Management activities and audit / inspection outcome
• Adherence to existing Policies and Procedures and ensure timely completion of relevant training
  

Who are you?

Education (add qualification if relevant) & experience:

• Education: Masters degree in a scientific discipline or equivalent by education and experience
• Experience: More than 5 years experience in the Pharmaceutical or Biotechnology industry with in-depth GCP knowledge
• ATMP experience is a plus

General skills :

• Current and strong knowledge of Clinical Development processes according to Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), other GxP guidelines and regulatory requirements.
• The ability to present complex issues in a way that is understandable cross-functionally and at all levels of the organization.
• Excellent problem solving, and analytical skills, including knowledge of root cause analysis tools / methodologies.
• Strong interpersonal skills resulting in an effective (intra- and cross-departmental) team player.
• A strong personality, a high degree of flexibility, assertiveness and excellent communication skills are essential to success.
• In addition, well-developed problem solving, decision-making and analytical thinking skills are highly desirable.
• Good communication / interpersonal skills and diplomacy are essential to be successful in the role.

Language Skills:
Fluent in English reading, writing and speaking.

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…!