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

Dev. Quality Lead Biosciences

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  65285

 Development Quality Lead Biosciences

 

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 Biosciences.

 

Are you driven and enthusiastic in your approach? For UCB, you are a ‘drivethusiastic’ person. This very special blend of talent means you are pushed by a keenness to make a positive difference for patients.

 

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

  • Lead QA project related activities in support of Product Development and the running of Development processes and facilities, including the Biopilot plant.  Thereby ensuring that all activities performed in support of product development are conducted in a way that ensures product quality, meets regulatory requirements and delivers business performance.
  • As an expert in BPS Development QA issues and member of the BPS and Clinical Supply QA team you will be acting both as an internal expert for BPS project teams and also driving the continuous QA improvement process ensuring that all systems and activities in support of BPS Development projects, including the review and the release of material for development and clinical trial supplies work in a way that ensures product quality, safety and efficacy meet regulatory requirements and expectations and delivers a competitive advantage in business performance.
  • Participate in the selection and approval process for external contractors for BPS Development activities, including those activities that are outsourced on long term contracts. This work will include support as expert the process of conducting appropriate
  • Provide guidance and advice to BPS Development scientists, particularly with regard to the appropriate interpretation of national and international GMP regulations and guidelines.

The role will also be responsible for leading participation in partnerships with other departments to identify, mitigate and subsequently resolve compliance and quality issues that may affect UCB development activities and products. These lessons learned once implemented, shall then form the basis for future cross functional and cross project training and improvement opportunities

 

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

 

Manufacture and certification of Investigational Medicinal Products, was according to:

    1. Principles of good Manufacturing Practices as required in Directive 2003/94/EC
    2. Article 13.3 of Directive 2001/20/EC related to the manufacturer or importer
    3. The related Product Specification File resp. Article 9.2 of Directive 2001/20/EC   
    4. 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.
  • Ensure the BPS project related QA activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house)
  • Ensure the QA project support of the BPS 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.
  • Ensure adequate documentation processes and systems are available and followed for BPS development projects (SOPs / Protocols review /Approval/Master Batch Record)
  • Proactively support the activities in-house and sub-contracted of BPS and Clinical supply for relevant manufacturing quality systems (deviation close out / Change management/ Out of Specification/ Complaints / quality improvement)
  • Acting as an internal expert, advise BPS development sub-teams and the wider BPS community regarding strategy, timelines, logistics and operational issues in order to assure regulatory compliance and ensure scientific consistency across BPS development projects. 
  • Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions 
  • Act as a “Quality Expert” and partner with the broader BPS community and individual project teams to address operational deficiencies identified by regulatory Agencies.

Keep knowledge current on BPS guidance and assist the Head BPS & Clinical Trial Supply QA in interpreting new guidelines rules and expectations as they pertain to BPS development processes

 

Process 

  • Ensure that all operations are appropriately compliant with applicable regulations (EMEA, FDA, DEA, MHRA, OSHA, DEC, etc.where relevant). As a quality expert drive preparations in support of the Head BPS & Clinical Trial Supply QA in ensuring an acceptable outcome of all audits and inspections, especially those by government agencies, as they pertain to Formulation Development, Process Development, Pilot Plant (where relevant), Process Support, and Package Development practices (where relevant), equipment, and facilities
  • Take an expert role in identifying, developing, leading and implementing local quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements by encouraging others both internally within QA and externally in other departments to seek opportunities for different and innovative approaches to addressing problems and developing solutions
  • Ensure BPS and Clinical supply QA processes directly support Technical Operations and development partner goals and objectives.

 

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

  • Bachelor or Master degree
  • Industrial Pharmacist & Qualified Person
  • Significant (at least 5 years) experience in pharmaceuticaI regulated environment.
  • Must be knowledgeable in QA and technical requirement of pharmaceutical development process.  
  • A good understanding of current regulatory requirement and expectations and an ability to interpret current regulations and requirements in the product development context is essential 
  • Experience in conducting customer / vendor audit. In managing regulatory inspection and PAI 
  • QA compliance experiencing IMP manufacturing, facility operation, laboratory compliance, and quality system.
  • Experience with sterile and or Biological product manufacturing quality assurance is desirable
  • Identify and facilitate resolution of problems (problems solver) issues that may impact the quality of the CMC sections of regulatory submissions 
  • Maintain the knowledge in the different regulatory requirement (see major accountability).
  • Good communicator. 
  • Be integer. 

 


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