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

Development Quality Lead

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  65060

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 our hub in Braine l’Alleud, Belgium, we are looking to fill the position of: Development Quality Lead.

Is your strategic aptitude second only to your analytical faculties? You're an ‘ analytegic’ person at UCB. This very special blend of talent means you are accomplished at plotting a course through deep reflection to improve patients' lives.

As a UCB 'analytegic' person and Development Quality Lead you like to work in an environment where you can:

 

  • Drive strategic and operational QA activities associated with products in development
  • Actively participate in the selection, evaluation and approval of third party contractors.
  • Partner with other departments to identify, mitigate and subsequently resolve compliance and quality issues.
  • For candidates with QP certification following additional responsibility would be:  Act as a Qualified Person according to Annex 13 and be responsible for the management of batch disposition and release activities

 

As a UCB 'analytegic' person and Development Quality Lead you will contribute by:

 

Operational

  • Ensuring Manufacture according to:
    • Principles of good Manufacturing Practices as required in Directive 2003/94/EC
    • Article 13.3 of Directive 2001/20/EC related to the manufacturer or importer
    • The related Product Specification File resp. Article 9.2 of Directive 2001/20/EC  
    • These requirements are fulfilled by taking into consideration the items summarized under Annex 13 rev 1 article 40, e.g. batch records incl. control reports, examination of finished products, audit reports, stability reports, etc.
  • For candidates with QP certification following additional responsibility would be: Acting as a QP for the Certification of DS and DP material used in Clinical Trials, and demonstrating compliance to the above mentioned requirements
  • Ensuring the CMC project related QA activities are consistent across the range of different environments and teams supported.
  • Ensuring the QA project support of the CMC process development and clinical supply including analytical work, manufacturing, review and release, technology transfer, CMC filing from early phase to commercial launch of the product.
  • Ensuring adequate documentation processes and systems are available and followed for CMC development projects
  • Proactively supporting CMC and Development QA Pharma Sciences activities for relevant manufacturing quality systems.
  • Acting as an internal consultant, advising CMC development sub-teams and the wider CMC community regarding strategy, timelines, logistics and operational issues in order to assure regulatory compliance and ensure scientific consistency.
  • Identifying and facilitating resolution of technical and manufacturing quality issues.
  • Ensuring all QAAs are in place and taking ownership of agreements between sites and the team.
  • Partnering with project teams to address operational deficiencies identified by regulatory Agencies.
  • Keeping knowledge on CMC guidance up to date and applying as appropriate to development processes.

 

Process

  • Ensuring all operations are appropriately compliant with applicable regulations.
  • Actively participating in identifying, developing and implementing local quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements.
  • Ensuring CMC and Development QA PharmaSciences processes while directly supporting Technical Operations and development partner goals and objectives.

 

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

 

  • Minimum 5 years’ experience in pharmaceutical regulated environment (either analytical or process development).
  • Preferably industrial pharmacist with Belgian QP certification
  • Must be knowledgeable in QA and technical requirements of pharmaceutical development processes.
  • A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential. 
  • Experience in conducting customer / vendor audits and participation in the management of regulatory inspections.
  • Experience with solid and liquid dosage forms and with sterile parenteral.
  • Certified auditor by official authorities is an asset.
  • Solid project management skills and ability to inspire confidence, facilitate and influence in a CMC development environment.
  • Able to give presentation to interdepartmental and multicultural audience in French and English.

 

 

To apply please go to www.ucb.com/careers.

Discover more about the remarkable UCB Talent Blends and how you can contribute to the mix at www.ucb.com/careers.


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