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Global Quality Lead, GMP Auditing & Compliance - Belgium  

Company managed [?] Still accepting applications

Posted on : 10 September 2017

Project Description

  • Independently analyse data and information to draw conclusions and make effective decisions
  • Help others solve problems in a creative and practical way through development of solutions from innovative problem solving activities
  • Engage with an analytical mind-set in order to understand global and complex compliance and regulatory issues and use negotiation skills and ability to influence a proper course of action 
  • Utilize excellent planning and organizational skills to deal with stressful situations and drive issue resolution and decisions


As a UCB 'agilytical' person and Global Quality Lead, GMP Auditing and Compliance you will contribute by:

 

Internal & External Auditing:

  • Support the creation and maintenance of the Global Audit Program, leveraging a risk-based approach for ranking and prioritization,
  • Support the Global Audit Program through the execution of Due Diligence audits, mock inspections, Routine GMP, For Cause audits and Pre-approval inspections as assigned per senior management,
  • Ensure the follow up on the above-mentioned audits, as well as timely CAPA closure,
  • Support the development and execution of the Auditor Qualification Program

 

GMP and GDP Quality Systems:

  • Take ownership of one or several Quality Systems,
  • Act as the UCB Subject Matter Expert and global resource for these systems,
  • Create and own the supporting UCB Policies and standards,
  • Oversee their deployment, periodic review by senior management, as well as their maintenance by leveraging the Regulatory Surveillance process and industry benchmarking.

 

Consulting, Educating and External Focus:

  • Act as an in-house Consultant and Educator to ensure that the UCB network remains up to date as regards regulatory and industry trends,
  • Provide technical and Compliance guidance as a member of selected committees,
  • Lead improvement initiatives, identified by senior management, in order to improve Corporate QA processes and effectiveness,
  • Partner with the UCB Network QA operational teams to prepare sites for pre-approval regulatory inspections, or routine regulatory inspections, as deemed necessary,
  • Keep abreast of regulatory and industry trends:  Share key information gathered via professional associations and regulators (upcoming regulations, best practices) across the UCB network and ensure they feed into Quality Standards.
  •  

    Compliance Issues:

  • Partner with colleagues/others to identify and mitigate Compliance risks, resolve potential regulatory observations,
  • Escalate critical Compliance risks to upper management.


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

  • Educated to a Masters level in a relevant scientific discipline (Pharmaceutical, Bio-Engineering, Microbiological or related science)
  • 10 years’ experience minimum in a Quality Assurance role, dealing with Biopharmaceuticals
  • Profound expertise within sterile and biological manufacturing operations
  • Extensive Audit experience is an absolute necessity
  • Experience with preparation and/or facilitation of regulatory inspections (FDA, ANVISA, KFDA, EMA, … ) is a strong asset
  • Fluent in English both speaking & writing (additional European languages advantageous)
  • Good knowledge of Trackwise
  • Excellent presentation and training skills
  • Willing to travel up to 30% on a global basis
  • Negotiation skills and a proven ability to influence others within a global matrix organization
  • Able to cope with stressful situations and drive issue resolution and decisions
  • Able to prioritize according to Compliance and Patient Safety risk


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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