Global Senior Project Manager (M/F)

Promethera Biosciences is a global innovator in liver therapeutics whose mission is to enable patients to overcome acute and chronic liver diseases. Our lead clinical program, derived from our patented cell technology platform HepaStem, is designed to benefit from its immune-modulatory and anti-fibrotic properties. In addition to our cell-based pipeline we develop antibody technologies, such as the anti-TNF-R1 antibody Atrosimab, to complement and diversify our therapeutic options. We are a team of international experts operating out of facilities in Mont-Saint-Guibert, Belgium, Durham, NC, USA, Tokyo, Japan and Basel, Switzerland.

If you are sharing our vision of becoming the world leader in regenerative medicine in the liver space by developing innovative advanced therapies for acquired liver diseases and if you are looking for new challenges amongst a dynamic and international team of more than 60 people, consider a collaboration with our fast-growing company. Promethera Biosciences is currently hiring a Global Senior Project Manager.

The selected candidate will have the following responsibilities:

MAIN RESPONSIBILITIES

  • Monitor all departments together, Product Development, Regulatory, Manufacturing
  • Perform a strategic Project ASIS to give a 360-degree picture of what is going on in the organization.
  • Report to C-level on an independent role, showing the whole circle of the activities and projects in the organization, is pro-active and takes the lead in notifying C-level of red flags, roadblocks when deemed necessary.
  • Master reporting and project management tools, mapping all projects, including, owners, timelines, budget, finance and build a dashboard with KPIs and measuring controls in place.
  • Manage & coach teams, triggering people to work together, creating harmony, understanding needs of C-level & stakeholders.
  • Keep deadlines, delivering, putting people to work in harmoniously way
  • Ensure close control and daily presence in all levels
  • Ensure that products are manufactured according to Promethera Quality System
  • Prepare, in agreement with upper management, adequate global planning and ensure timelines are respected
  • Draft or revise and approve departments instructions and verify their exact execution
  • Verify batch records and transfer these in a perfect state to the Quality Department on a timely manner
  • Ensure that maintenance of plant and equipment is performed adequately
  • Ensure that validations and qualifications of people, process and equipment are performed adequately in coordination with Quality Assurance department
  • Ensure that personnel training (initial and continuous) is performed as per the quality system and registered adequately
  • Review and approve all production documents (SOP, checklists, batch records, validation protocols and reports, change notices, deviations, etc.)
  • Ensure adequate monitoring and status of environmental conditions in the production, manufacturing & R&D area
  • Ensure adequate control of the subcontractors involved in production activities
  • Ensure respect of cGMP rules in cross-functional view in all departments
  • As the final responsible person, prepare and manage the budget of each department
  • Report the department activities on a monthly basis to the C-level and organize weekly meetings with the team
  • Consolidate, as strategic mature PM, excellence at assembling divisions, connecting and aligning people.

QUALIFICATIONS

  • Bioengineering or master’s degree in sciences or relevant experience
  • Minimum 10 years in the Pharmaceutical or Biotechnology industry, with Quality Assurance mindset, including at least 3 years of people management
  • Excellent knowledge of cGM
  • GreenBelt / BlackBelt Lean Six Sigma certification/ Prince 2/ Scrum/Agile methodology
  • Experience in cell therapy R&D & manufacturing
  • Proven leadership, ownership and managerial skill
  • Excellent organization skills
  • Quality minded, autonomous, rigorous and pro-active
  • Demonstrated teamwork and coaching skills
  • Excellent communicator
  • Excellent knowledge of English & French, other language is an added value
  • Mastery of Microsoft office tools, MS Project Management

LOCATION

At our headquarters in Mont-Saint-Guibert  / Gosselies, Belgium

You may apply for this position by sending your CV and application letter to HR@promethera.com

Please note that, due to the high number of applications we receive, only retained candidates for interview will be contacted.

 

For information, resumes and application letters received will be retained as long as the employment’s offer is valid and will be destroyed as soon as the position is filled. We will contact you in case we wish to keep your CV after the recruitment period.

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