Ethics & Compliance Process Excellence Lead

il y a 2 semaines

Anderlecht, Région de Bruxelles, Belgique UCB S.A. Temps plein

Make your mark for patients


We are looking for a highly skilled
Ethics & Compliance Process Excellence Lead who is
meticulous, conscientious and
agile to join our
Ethics & Compliance Strategic Operations team, based in our headquarter in Brussels, Belgium.


About the role:


As an Ethics & Compliance Process Excellence Lead, you will design and implement an E&C framework for management of policies, procedures and related documents for UCB's healthcare compliance related activities.

The scope will include all aspects of healthcare compliance and ethical business practices with a focus on all healthcare compliance regulations and guidance relevant to UCB's activities.

This includes conducting impact assessments of emerging regulations and trends related to post and pre-approval activities related to healthcare compliance.


Who you'll work with:


The Ethics & Compliance Process Excellence Lead will design a framework to govern, organize, coordinate and implement documentation on healthcare compliance activities, collaborating with stakeholders and process owners at a global and local/regional level.

This individual will drive an approach of harmonization, comprehensiveness and simplification, in order to deliver maximum effectiveness of UCB's healthcare compliance standards.

He will also drive the definition and implementation of Knowledge Management program for E&C. This position will be required to establish close partnering with process owners and especially with key stakeholders of Document Management within UCB like GxP corporate governance and

What you'll do:

  • Lead the development, implementation and maintenance of a framework E&C Documentation Management System in order to enable design of processes, including continuous improvement, agility and focus on business effectiveness and efficiency for people, processes, and systems for processes related to healthcare compliance, through collaboration with relevant process owners and stakeholders and alignment with GxP QMS.
  • Manage the Process Excellence Coordinator team to ensure they meet all objectives and deliverables.
  • Stay abreast with regulatory and industry trends and integrate new requirements into documentation as needed. Share key information gathered via benchmark (upcoming regulations, best practices) within the E&C Leadership Team and relevant stakeholders.
  • Has the oversight of functional End to End (E2E) Documentation Architecture for documentation within the scope of healthcare compliance (link between standards).
  • Oversee assessments for creation of local documentation, including the Gap Analysis phase.
  • Foster change management culture to facilitate adoption and usage of new standards.
  • Drive overall communication on QMSrelated topics within E&C organization.
  • Maintain a healthcare compliance documentation plan or a roadmap.
  • Define and deploy a Knowledge management program across E&C.
I
nterested? For this role, we're looking for the following education, experience, and skills:

  • Bachelor degree and 8 or more years of experience in GxP or Non-GxP environment (preferably in the biosciences, medical devices or pharmaceutical industry)
  • Good writing skills (crystal clear /plain language writing skills)
  • Good training and facilitation skills, storytelling skills
  • Ability to articulate customers' needs and concerns and translate it in a consensus
  • Energetic, creative, open communication style, tactful and diplomatic, with good interpersonal skills and the ability to develop effective crossfunctional relationships
  • Interest or skills in relation with behavioral or social sciences (what motivates employees, how to make them work more effectively, what influences this behavior, and how to use these patterns in order to achieve the company's goals)
  • Knowledge of EDMS / ECMS systems especially quality documents (Controlled Documents)
  • Project management and influencing skills
Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you

About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work for us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients.

We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work.

We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees or our planet.

Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.


Learn more about sustainability at UCB and how it is integrated into our busine

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