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Campus Quality System Senior Manager (H/F/X)

September 27th 2022

Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, Catalent’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients.

Mission Description

Reporting to the Quality Director, the Campus Quality System Sr Manager together with the team of PQS Business Process Owners, is accountable for:

  • The implementation and maintenance of all Pharmaceutical Quality Systems on Catalent Gosselies Campus Cell and Gene Therapy (Deviation & OOS, Change Control, CAPA, Complaints, GMP Training, Documentation, Inspection and Customer Audit, Internal audit/self inspection, …)
  • Making PQS Processes and Systems simple, effective, practical, robust and agile to ensure they will be a competitive advantage for our company in our capacity to deliver quality products and support our patient’s health in all we do  
  • The continuous Improvement and compliance to applicable regulation of all the Pharmaceutical Quality Systems
  • Prepare and deliver adequate training of appropriate site personnel so they can flawlessly apply these Processes and Systems
  • Deliver the annual quality training (update on company quality trends, regulation, and specific issue)
  • Monitor and ensure the adherence to these Processes and Systems by all campus personnel through implementation of actionable metrics and reporting hereof to appropriate instances (Tier Boards, Individuals & Team Leaders, Site Leadership Team, Corporate Catalent)
  • Hosting and/or Supporting audits and inspections (preparation, hosting and post-inspection response coordination and CAPA implementation)
  • Performing or Supporting Supplier audits
  • Performing Site and Campus Quality Management Review with the Board of Director and company local leadership team.
  • Ensuring compliance with Data Integrity regulation and identified risks
  • Creating and maintaining the campus and site Risk Register
  • Ensuring the appropriate support to Campus Quality Director and colleagues regarding the design, effective implementation, monitoring and maintenance of the quality management system of the ATMP manufacturing, importation, distribution entity and the Human Body Material (HBM) establishment 
  • Identify and determine quality improvement and recommend/implement appropriate solutions.
  • Managing the Outsourced activities, supplier, cell banks
  • Ensure to have outsourced, supplier, cell banks activities quality system documents up-to-date.
  • Ensure to have external audit quality system documents up-to-date.
  • Establish an annual external audit plan in collaboration with corporate
  • Ensure that the annual audit plan is respected and follow the progress with KPI.
  • Realize external audit
  • Ensure the CAPA follow up with KPI
  • Establish and approved quality agreement with Sub-contractors, Suppliers and Cell Banks.               
  • Create and maintain a compliant Vendor Management System of the Catalent Gosselies Campus Vendors aligned with company deliverable and risk management
  • Managing and endorse the responsibility as Deputee Responsible Person of Human Body Material
  • As a team leader (10+), the role holder will be accountable for a team of PQS Business Process Owners. A key mission for the role holder will be to:
  • Ensure Health, Safety and Well Being of the team
  • Create a Great Place to Work (GPTW)
  • Enhancing team performance and satisfaction of its customers
  • At all moments, ensure appropriate staffing of the team in terms of FTE as well as capabilities
  • Team pipeline development (including hiring, coaching, setting expectations, defining objectives and developing team members)
  • Ensure internal & external customer satisfaction regarding the team deliverables (processes, systems, service to customer,…) and continuous improvement hereof
  • As part of your role in Quality Assurance, you will contribute to ensuring product quality, external customer satisfaction and the surveillance of the site's compliance status.

Candidate profile

  • Education in sciences field, master degree preferred
  • 10-15 years experience in a Quality or Regulatory position within the Pharmaceutical, Biotechnology
  • Experience working in a medium to large sized organization (min. 200 people)
  • Previously worked within an internationally operating organization in people management position
  • Fluent in French and English, any other language is a plus
  • Promoting digital solutions
  • Ability to influence others / convey ideas and opinions
  • Capability to understand “product-patient-illness-treatment”-relation and ability to assess health risks and impacts as well as compliance and financial risks
  • Have in depth understanding of the pharmaceutical product lifecycle management
  • Ability to lead & manage people, give feed-back & coach
  • Problem solver
  • Good communicator (including presentation skills)
  • Technical writing skills (reports)
  • Capacity to synthetize complex situations
  • Customer/Business oriented with ability to protect boundaries
  • Team player
  • Entrepreneur attitude with Continuous Improvement attitude
  • Innovative, creative & pragmatic
  • Ability to make bold and timely risk based decisions with energy and accountability in ambiguous situations
  • Energetic, resourceful, dynamic, optimistic and resilient
  • Promotor of sustainability (in all its forms and meanings)
  • Emotionally intelligent
  • Strategic thinker

Offer

  • Delivers Results
  • Leads with Integrity and Respect
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

Contact Details

https://careers.catalent.com/us/en/job/0070295/Campus-Quality-System-Senior-Manager