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Let's push the boundaries together and make the most of your talents!

Qualified Person deputy

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  66388

 

QP Deputy

Quality assurance departement
Location: Braine l’Alleud, Belgium

 

Help us transform patients’ lives.

 

At UCB, we put our heart, soul and skills into making a difference for people living with severe 
disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.

Will you join us in our pioneering adventure?

To strengthen our Global Quality Assurance department, based in Braine l’Alleud, Belgium, we are looking to fill the position of: QP Deputy.

As a UCB QP Deputy you like to work in an environment where you can:

  • Assure the operational activities associated with the disposition of cell banks, biological drug substance and drug product (monoclonal antibodies or related diluent) for commercial purposes.

This will be achieved through close working and partnering with UCB Supply and Technical Solutions, other UCB teams and external parties.

 

As a UCB QP Deputy, you will contribute by:

  • Providing Quality Assurance expertise and capability for the review of production and Quality Control documentation associated with the manufacture of cell banks, drug substance and drug product for the commercial supply of biological products.
  • Coordinating and prioritizing disposition activities with the relevant team members.
  • As designated Qualified Person (in Europe) and Responsible QA Person (rest of the world), in collaboration with the Head of QP, disposition cell banks, biological drug substance and drug product (monoclonal antibodies or related diluent) for commercial purposes, including regulatory compliance for US, EU and rest of the world markets. Being the back-up QP for development biological products. Perform QP SAP transactional product release.
  • In the scope of preparation of launches to new countries and in collaboration with Regulatory Affairs, participating to QA assessment of approved dossier and defining action plan related to batch release.
  • Maintaining Quality System elements associated with the GMP disposition activities in a compliant manner.
  • Driving/Supporting projects related to quality systems improvement.
  • Working closely with the appropriate Supply & Technical Solutions teams to ensure that all QA services for Commercial QA activities are provided in an effective and efficient way and that product is dispositioned in a timely manner in accordance with schedule and planning for launch in new countries
  • Working closely with the Corporate QA teams, local QA teams and key Supply and Technical Solutions teams.
  • Maintaining key performance indicators (metrics) for key operational QA activities and services associated with the disposition of Commercial Biologics
  • Maintaining GMP compliance and inspection/audit readiness at all times. Supporting the Biologics Quality Operations team in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitments
  • Reviewing and evaluating Product Quality Review reports.

 

Interested? For this position you’ll need the following education, experience and skills:

  • Master’s degree and certified as a Qualified Person with minimum of 5 years working in the pharmaceutical/biologics industry in a quality management position, including operational GMP experience
  • Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has a deep knowledge of the pharmaceutical industry from a business and technical perspective.
  • Experience interacting with regulatory bodies and third party organisations with respect to QA systems and regulatory inspection preparedness.
  • Possess good auditing capabilities and skills
  • Must fulfil the obligations of the Qualified person as described in Eudralex Annex 16 to the EU Guide to Good Manufacturing Practice
  • Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments.
  • Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.
  • From a behavioral perspective, generate commitment from within teams, encourage and support new ideas and act as a role model for others in driving the departmental/company vision.
  • Be able to coach/train/mentor colleagues and team members and deliver training within area of expertise.
  • Set challenging objectives for self and drive for results using the resources available in an efficient and effective way. Take accountability for decisions and actions taken.


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