Distribution Quality Lead Europe - Mechelen,BE

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Basel (Switzerland) and in Boston (US).

We are 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 want to challenge the impossible.  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.

 

We are looking for a Distribution Quality Lead Europe - Mechelen,BE

 

Scope of the job:

 

You will act as the Responsible Person Europe for Galapagos. You define and implement an effective and efficient Quality Assurance System related to the Distribution activities of Galapagos in Europe. You will ensure the day to day work is performed in a lean and efficient way and meet the compliance standards of Galapagos and the local Regulators.

 

Your accountabilities:

 

Quality Management

As Responsible Person, lead Galapagos, based on thorough regulatory knowledge, in establishing a compliant and effective European Distribution Quality organisation. You maintain an excellent knowledge of the Galapagos Quality Standards and local regulatory requirements. You are strongly connected with the commercial teams, and help seeking opportunities with regards to warehousing and distribution activities as needed. You gain an understanding of the Supply Chain and Commercial Business and establish a Quality Plan tailored to the Regulatory and Business expectations.

Quality Systems

As Responsible Person, support the local teams to ensure that internal procedures and systems related to warehousing and distribution are in place and in use in full compliance with local regulatory and Galapagos requirements. You are responsible for ensuring the day to day work related to the distribution activities are flawlessly performed.

Inspection

Act as primary contact related to regulatory inspections in light of the Galapagos Wholesaler Distribution Authorisation.

 

Risk Management

Perform activities to support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks identified in warehouse and distribution activities.

 

Management of Distributor/ Logistics Service Provider/ Contractor:

Ensure there is a process in place to allow all new and existing suppliers/ 3rd party contractors/ service providers that have a direct impact on product quality in the distribution chain.

 

Deviations and Corrective and Preventative Actions (CAPA):

Effectively manage corrective and preventative action plans linked to warehousing and distribution, conduct root cause analysis to investigate deviations and develop CAPA’s. You ensure local processes are in place to track and review CAPA plans on routine basis while ensuring appropriate Quality governance is and Quality metrics in place.

 

Change Control

Establishes and maintains a change control process related to all major changes impacting warehousing and distribution so that they are effectively and compliantly managed.

 

Incident management

Establish and maintain an effective local product incident process to escalate and manage any product quality related issues identified in the warehousing and distribution activities in line with the established policies and agreements.

 

Complaints

Ensure the complaints management process is well established throughout the network and reports and follows up on product complaints with manufacturing sites, customers and commercial teams.

 

Contact with Regulatory Agencies:

Ensure reporting and communication to authorities is done in line with the WDA license and Responsible Person role expectations. 

 

Requirements

Who are you?

  • At least 5 years of relevant professional experience in a Responsible Person/ Qualified Person function within a pharmaceutical setting.
  • RP/QP Certification
  • Strong knowledge and experience in Good Distribution Practices.
  • Good knowledge on effective quality documentation systems.
  • Excellent understanding of the risk based approach.
  • Ability to deliver clear communications and foster excellent working relationships with peers and management.
  • Analytical mind, excellent problem solving skills, well organised, manages complexity effortless.
  • Excellent team player – works well in cross-functional teams and matrix organisations.
  • Excellent skills to differentiate major from minor issues, sees and understands the big picture and acts upon.
  • Flexible thinking – able to challenge and see views from different perspectives and is not shy to propose new things.
  • Very good communicator with an ability to discuss on executive level within Galapagos as well as externally (Dutch and English)

What’s in it for you?

You will be part of a fast growing and amazing company.  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…!