Quality Lead PreClinical

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Date: Jun 13, 2019

Location: Braine L'alleud, Walloon Brabant, BE

Quality Lead PreClinical

 

Location: Braine L'alleud, BE

 

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 team, based in our hub in Braine, Belgium, we are looking to fill the position of:

 

Quality Specialist PreClinical Quality.

 

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 Quality Specialist PreClinical Quality you like to work in an environment where you can:

 

• Partner with Non-Clinical Development (and related departments) in facilitating the quality mindset into the preclinical portfolio across the UCB sites (Braine and Slough). 

 • Provide direct compliance and investigative support to areas of research operations which are within the scope of the Good Laboratory Practice (GLP) Compliance Programme, and the Good Clinical Practice (Laboratory) Guidelines (GCP Lab).

• Provide guidance and support to Discovery Research in the implementation of basic principles of Good Research Practice (GRP).

 

As a UCB 'drivethusiastic' person and Global Quality Lead Preclinical, Auditing Systems & Compliance you will contribute by:

 

• Executing the management and development, maintenance and execution of a robust QA Programme to ensure ongoing GLP and GCP Lab compliance at the Braine site, and robust safety data in support of our UCB products. 

 • Ensuring multi-site study obligations including the Sponsor QA roles and responsibilities are met.

• Assessing the capabilities of potential vendors of non-clinical and ancillary services in GLP-regulated and GCP Laboratory activities at the local or global level, whilst working collaboratively with business stakeholders.

 • Undertaking the development and implementation of Good Research Practice (GRP) principles and partnering with Discovery Research to create ongoing training and awareness for the research teams on the importance of patent and intellectual property (IP) protection.

• Compiling and delivering the reporting to business and QA Senior Management of the ongoing status of the nonclinical programmes relative to quality risks and outcomes.

• Performing the generation of a summary and analysing the compliance and data integrity issues that have been observed for the QA programme activities, for upper management.

• Developing and maintaining cooperative relationships with new and existing business partners.  Identifying partner issues and propose appropriate solutions.

• Maintaining harmonisation of work practices (SOPs and tools) which raise regulatory confidence whilst eliminating areas of non-value added activity.    

• Acting in an advisory role for key internal customers and to assist with the definition and monitoring of key performance indicators (KPIs) with partnering teams.  To proactively assist internal teams with the identification, development and implementation of quality improvements.

• Ensuring the maintenance of a comprehensive PQA Vendor Management Programme for non-clinical QA services contracted to organisations that are regulated by Good Laboratory Practice Regulations and GCP Laboratory Guidelines, through communications with business stakeholders.

• Supporting the Head of PQA who will have the capability and capacity to serve as the primary liaison during inspections and investigations conducted by international and national regulatory authorities, including any synergies across various sites related to audit observations will be disseminated and implemented appropriately.

• Maintaining proactive approach to current regulatory thinking and trending through key regulatory and industry relationships

 

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

 

• Seasoned QA professional with a robust knowledge and understanding of the UK, EU and FDA regulations (GLP), as well as the UK/EMA GCP Laboratory Guidelines.  

• Able to demonstrate the necessary attributes and behaviours for working with research scientists when discussing quality matters.

• Mindset that demonstrates the confidence, resourcefulness and willingness to tackle any assigned task and get it done in the face of any challenges that may arise.

• Flexible and adaptable, have a capability of leading and motivating projects with interdepartmental teams, plus innovative problem solving skills are essential.  

• Excellent interpersonal and communication skills are a prerequisite.

 

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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