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Head of Quality Operations – Vaccines or CDMO (cell & gene therapy) (M/F)

October 15th 2020

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

You will be responsible for the quality operations for the concerned subsidiary of Univercells (Univercells Vaccines or Exothera), as well as for the quality of all active biological/pharmaceutical substances and final drug products being developed, manufactured, released and distributed for use in clinical trials and for commercial sales.

By preference, you can act as Qualified Person for the release of the products. 

Operationally you will report to the General Manager of the subsidiary and functionally you will report to the Chief Quality Officer.

RESPONSIBILITIES

  • You will define the quality strategy for your area of operations
  • You will build, lead, coach and develop the QA Operations team to ensure appropriate QA oversight and implementation of the PQS;
  • In cooperation with the corporate Quality team, you will establish, implement, maintain and continuously improve a pharmaceutical quality system (PQS) for the development and manufacturing activities of the subsidiary;
  • You will maintain the quality of the development and manufacturing process, as well as the output thereof
  • You will disseminate quality mindset throughout the company and act as a role model;
  • You will ensure appropriate QA/PQS reporting throughout the organization;
  • You will participate in health authority inspections and/or customer audits and ensure appropriate quality actions are being developed.

Candidate profile

  • MSc in Life Sciences or (Bio) Engineering
  • Ideally, you can act as a Qualified Person under the Belgian health authority supervision
  • Minimum 15 years’ combined experience in the operational area (cell and gene therapy or vaccines)
  • Executive and leadership capability to manage people, as well as influential skills
  • Strong GMP knowledge, covering EU and FDA (WHO experience is a plus)
  • Proven track record in inspection/audit 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

Offer

We offer a long-term contract, a competitive salary package (health insurance, company car, pension plan, meal vouchers…) and the possibility of evolution in an international, dynamic and fast-growing company.

Contact Details

Is it appealing to you? Are you a powerful thinker combined with an efficient doer? Do you excel in bioproduction and downstream processes?  Apply now!