External Manufacturing Operations Associate

工作内容

The External Manufacturing Operations Associate function is also a steppingstone to the role of EMO Lead. He / she could be asked to manage the operational relationships between UCB and the least troublesome CMO’s and Vendors.

In this context, your main accountabilities will be:

• Support EMO Leads in the creation and management of Change Controls (CC) related to CMO’s. After some time, the support lead should autonomously handle most of the CC process. Including:
• Understanding the business need and create a first draft of the CC using UCB’s templates.
• Identify the proper stakeholders.
• Use UCB’s document management system to manage modifications to the CC in draft mode.
• Stakeholders’ management within the set deadlines before asking to join the correct Change Control Committee.
• May defend the CC in front of the CCC with the help of the EMO Lead/Vendor teams.
• Once approved by the CC Board, input the actions in UCB’s Quality Management System and assign them to the proper stakeholders.
• Follow-up the actions to ensure that they are accomplished within the set deadlines
• Support EMO Leads in the management of deviations where the root cause and/or CAPAs have already been identified and put in place. Tasks include transferring the PR into UCB’s Quality Management System and following up on any pending actions.
• Double check Qualification and Validation Reports to spot errors or any other relevant reports coming from CMO’s or Vendors.
• Ensure that all changes to MBRs are documented in the change log.
• Contact and follow-up CMO’s or Vendors about the yearly Green Surveys or any other surveys. Assist them if they need help to fill them in and compile the results.
• Encode CMO KPI’s in Quickscore.
• Operational Management Reviews: assist the slide preparation if requested by an EMO Lead.
• Ad-hoc support on various EMP Projects: CoGs reduction, Process improvements, Digitalization, …

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

• Master’s Degree preferred in Chemical Engineering or related fields.
• At least 2 years of experience in a relevant operational management GMP environment.
• Experience in Pharma Project Management.
• Technical knowledge / expertise in the related focus areas.
• Very good command in English (both written & spoken). Good command in French is a strong asset.

Soft skills:

• Being motivated and having the willingness to learn and develop within the team.
• Able to influence others, hold teams accountable, results orientated.
• Able to manage external business partners.
• Strong communication and networking skills with both external and internal partners.
• Strong both analytical and conceptual thinking.
• Fully self-supported.

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.