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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:  68315

Development Quality Lead

 

Help us transform patients' lives.

 

At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases.  Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in this pioneering adventure? 

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

 

As a UCB 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.
  • Experience on combination product, in particular on Dry Powder Inhaler, is highly appreciated

 

 

As a UCB Development Quality Lead, you will contribute by:

Operational

  • Ensuring the CMC project related QA activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house).
  • 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 (deviation close out / Change management/ complaints / quality improvement)
  • 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).
  • Experience on combination product, in particular on Dry Powder Inhaler, is highly appreciated
  • Experience with solid and liquid dosage forms and with sterile parenteral.
  • Experience in medical devices is a highly appreciated
  • Must be knowledgeable in QA and technical requirements of pharmaceutical development processes.
  • Very good understanding of GMP requirements, processes and analytical activities
  • 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.
  • 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.

 

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

Apply now »