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QA Operations and Validation Manager

Mont Saint Guibert, Belgium

The mission of Cellistic/ Ncardia Belgium is to understand human iPSC and developmental biology and harness this knowledge to develop and manufacture iPSC therapeutics that significantly improve patient outcomes. We are convinced that pluripotent stem cell technology is the key to getting better, more efficient treatments to patients faster. To achieve this mission, we are building a world-leading research facility to overcome the complexity and challenges of iPSC lineage specification. We will know we have succeeded when we can reliably and rapidly generate cell products that consistently produce positive outcomes in patients.

Within our Cell Therapy team in Mont-Saint-Guibert (Belgium) there is a position immediately available for a QA Operations and Validation Manager. The selected candidate will report to the QA Director & QP. We are an enthusiastic, skilled, and committed international team in which everyone has the opportunity to make a decisive contribution.

For more information about the company, please visit our website at www.cellistic.com

 

Responsibilities

QA Validation

  • Participate in validation strategies for Cellistic operations:

    • Transfer of technologies from MSAT to GMP environment

    • Validation of production operational activities

    • Analytical method development, transfer and validation

    • Material qualification

  • Maintain up-to-date Validation Master Plan (VMP)

  • Transversally work with QA system team and operations teams on QMS compliance with regards to the validation activities

  • Organize quality review and approval of development, transfer and validation documents (i.e. protocol and reports, SOPs and associated documents)

  • Organize quality oversight of validation activities

QA operations

  • Define the quality operational flows and processes applying to Cellistic operations

  • Define the release processes from incoming materials to end-product (DP)

  • Participate in interdepartmental operational meeting to proper follow-up on planning and client projects, and on investigation / change management

  • Participate to the release of incoming material and intermediate products

  • Organize Drug Product release flow up to QP certification

  • Coordinate risk management in operational activities with key stakeholders

  • Manage approval deviation reports, change controls and CAPA related to Cellistic operations

  • Coordinate quality complaint investigations with Operational departments and QA

  • Participate to internal and external audits and ensure follow-up of actions

  • Participate to the inspection and Client readiness activities (in support to QA System function)

  • Organize Quality oversight of GMP, CLD and MSAT operations

People management

  • Plan, coordinate, manage and control the day-to-day activities

  • Manage a team of QA technicians and specialists. People development and management responsibilities to include new hires selection and onboarding, regular feedback and skills development, documentation and delivery of annual performance reviews, on-going coaching and counseling, determination of necessary resources and implementation of strong team spirit

  • Act as primary quality operations & validation point of contact for the other teams inside or outside the organization. Develop and drive a clear and comprehensive communication channel within the team and with other teams

  • Establish highly effective technical capability within the team.

  • Ensure that the team efficiently deliver on their KPI’s, in respect of safety & quality standards and business deadlines

  • Budget management and control of the team

Qualification & Experience

  • Master in Pharmaceutical Sciences, Biology, Chemistry, Biomedical Sciences, Biotechnology Engineer

  • Desirable: Qualified Person accredited under Belgian Royal Decree of 14 December 2006

  • Min 10 years' experience in quality assurance function within pharmaceutical or biotechnology industry

  • First experience in people management role

  • Advanced knowledge of GMP and pharmaceutical industry standards 

Skills & Competencies

  • Excellent interaction & communication skills, required to work across departments

  • Highly developed organizational skills

  • Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes

  • Can do attitude and Hands-on approach

  • Self-motivated, enthusiastic personality, team player

  • Problem solver

  • Languages: Fluent in English and French

  • Proficient knowledge of Office 365 applications (Word/Excel/Access/PPT)

Job Location: Mont Saint Guibert, Belgium

Position Type: Full-Time

Start Date: Immediately

We offer you a challenging position in a dynamic biotech company with room for personal growth and development. We provide a competitive salary package based on your education and experience.

Interested?

Send your motivation letter with curriculum vitae to: careers@cellistic.com