Medical Safety Quality Lead - Contractor (4 months), Leiden or Mechelen

Pleased to meet you, we are Galapagos , a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life.

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 CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.

Scope of the project:

Actively participate to the initial Gap Assessment phase (process mapping, process prioritization by criticality, SOP framework comparison and action plan definition) of the SOP harmonization initiative:

• Bring hands on medical safety expertise to the team effort specifically regarding regulations inputs
• Support process criticality definition,
• Ensure proper mapping and comparison between mapped processes and SOP framework,
• Ensure that identified gap remediation is articulated into a relevant action plan

Act as SOP technical writer and support medical safety partners in SOP writing and implementation

• Write the procedural documents based on the outcome of the gap assessment and action plan definition, and based on the input from the operational teams
• Coach the medical safety partners in the implementation and training of the revised and/or new procedures
• Coach the partners in SOP maintenance

The position is preferably located in Belgium (Mechelen) or the Netherlands (Leiden) but can be also remote as long as the candidate could physically attend the workshops related to the project and ensure continuous alignment with the project partners

Who are you?

• Education: Masters degree in a scientific discipline or equivalent by education and
  experience
• Experience: More than 10 years experience in the Pharmaceutical or Biotechnology
  industry with a minimum of 2 years in a Quality Management environment
  General skills
• Current and strong knowledge of Clinical Development processes according to Good
  Clinical Practices (GCP) and regulatory requirements.
• Notions of other GxP requirements
• The ability to present complex issues in a way that is understandable crossfunctionally
  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 Quality Management role.
  Language Skills:
• English proficient knowledge is required

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.