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QA Manager Supply Chain (H/F/X)

March 2nd 2021

At Univercells, we are on a mission to make health equally accessible to all. We work every day to reinvent biomanufacturing processes, and develop or integrate the next innovative technologies. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: Biologics available and affordable to all!

Mission Description

  • Build, lead, coach, and develop the Supply QA team and organization.
  • Establish and manage the team budget to meet targets while ensuring department efficiency and regulatory compliance of the QA activities.
  • Lead, develop and implement quality strategies for the procurement and external supply operations for Univercells’ subsidiaries to ensure quality in the supplier’s deliveries.
  • Establish, implement, evaluate, and improve the Supply QA processes and provide training when necessary, including supplier qualification and certification program.
  • In cooperation with corporate quality management, develop and maintain a comprehensive Quality Management System.
  • Establish confidence in suppliers and their production processes by performing supplier evaluations, supplier risk assessments, and continuous follow-up.
  • Ensure continued GMP compliance for suppliers.
  • Reduce supplier mistakes and costs related to material non-conformity (proactive and reactive, e.g., complaints)/
  • Handling supplier-related changes, deviations, issues, and litigations.
  • Ensure supplier business continuity.
  • Disseminate and promote a quality mindset throughout the QA staff and business partner teams.
  • Develop quality tools to support a quality culture.
  • Drive a continuous quality and compliance improvement mindset within the organization and at suppliers and third-party sites, such to ensure compliance with cGMP's and the company’s QMS.
  • Provide adequate QA/QMS reporting on the supply operations.
  • Coordinate and accompany supplier audits.
  • Ensure establishment and handling of corrective and preventive action plans at supplier’s site following audits, as needed.
  • Represent Supply QA during customer or partner audits and health authority inspections
  • Ensure establishment and handling of corrective and preventive action plans following audits and inspections, as needed.
  • Promote and ensure the application of the company’s values within the QA staff and cross-divisional teams.

Candidate profile

  • MSc or equivalent in a scientific discipline, engineering, or related discipline with the required skills, knowledge, and abilities that are typically acquired through experience in supply chain quality environment in the medical device or pharmaceutical industries.
  • 10+ years experience in biotech/vaccines/pharmaceutical industry
  • Advanced knowledge of supplier quality requirements and extensive knowledge in GDP
  • Leadership capability to manage people, as well as influential skills
  • Strong GMP knowledge, covering EU, FDA and WHO
  • Proven track record in supplier management
  • Strong in communication and team player
  • Ability to work in fast-paced environments and to combine helicopter view and tactical actions
  • Fluent English (both written and spoken), French is an asset.
  • Demonstrate day-to-day application of the company’s values.
  • Ability to travel as required for business requirements, sometimes on short notice

Offer


For more information please contact to Univercells

Contact Details

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