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Human Biological Samples Operations Specialist

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Research & Early Development
Job ID:  64500

New Medicines Operations Belgium

HBS Operations Specialist

Location: Braine l’Alleud

Business Purpose:

The Human Biological Samples (HBS) Operations Specialist role provides business and technical expertise and drives for excellence within operations, processes, documentation and compliance with R&D regulations within New Medicines, with global reach, challenge and influence.

To undertake this role, the HBS Operations Specialist has a strong understanding of the core business activity of New Medicines, as well as operational skills in order to effectively engage with varied stakeholders and ensure the broad remit of the role.

Business Scope:

Under the direction of the Head of Operations the HBS Operations Specialist is responsible for the operational management of Human Biological Samples processes and reporting to relevant authorities in compliance with the legal requirements in Belgium and the EU data privacy legislation.

The HBS Operations Specialist, in collaboration with the UCB Biobank Manager and the UCB Biobank Committee, is driving the maintenance of an HBS compliance program within the Braine-l’Alleud Research site.

In addition the role ensures organizational efficiency and contributes to business quality process improvement initiatives across New Medicines in order to streamline, simplify, standardize processes to enhance operational efficiency and increase compliance level. 

Major Accountabilities:

  • Ensure deployment of the Human Biological Samples (HBS) Quality Management System in compliance with the legal requirements in the EU, including Belgium and UK in particular.
  • Ensure accurate inventory, tracking and reporting tools are in place on acquisition, use, storage, transformation, transfer and destruction of HBS within the UCB Biobank in Belgium.
  • Ensure the HBS database (Item Tracker Infinity) is compliant with the relevant regulations and ensure annual reporting of HBS use to legal authorities.
  • Ensure donor consent forms, ethics approval(s) and tissue procurement/transfer agreements are adequate with the HBS intended use, and appropriately recorded in the HBS database.
  • Support the UCB Biobank Manager and the UCB Biobank Committee in their mission and liaise with the external Ethical Committee on all HBS-relevant matters.
  • Organize regular UCB Biobank Committee meetings with input from scientific, clinical, legal, Health and Safety and Quality Assurance staff.
  • Contribute to the writing of relevant SOPs and documentation on matters relating to human tissue use, storage and tracking.
  • Train and educate colleagues on HBS processes, tracking and documentation, and provide guidance on these matters.
  • Participate in and respond to the actions of internal and external inspections and audits to ensure that actions are tracked and followed up on.
  • Liaise and build business relationships with key internal stakeholders from different functional areas (Scientists, Legal, Health and Safety, Preclinical Quality Assurance ) to ensure practices and procedures are compliant with relevant regulations and corporate policies.
  • Keep up to date with new best practices and provide continued communication, advice and support to all staff on HBS related matters, adopting and championing best practices.

Education/Qualification:

  • Biological science or biomedical background and hold a BSc level (or equivalent) qualification in a relevant discipline
  • Knowledge of the ethical and practical considerations that apply to the handling of human samples and biological materials
  • Proven experience under GxP (GLP, GCP) regulations and quality/compliance
  • Knowledge in ECMS (Electronic Content Management Systems)
  • Experience of working in pharma industry, knowledge of pharmaceutical development processes and scientific deliverables

Competencies:

  • Excellent planning and organizational skills
  • Priority management, ability to work on multiple objectives
  • Very good communication skills (written and verbal) in both English and French
  • Analytical and process minded
  • Team player, team building skills
  • Extensive computer skills
  • Customer and quality focused
  • Service management, problem-solving, solution driven

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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