Based in Brussels or Nivelles or Gosselies you will join a collaborative team full of passionate change-maker.
Your mission: overall responsibility for the management of the quality of materials and components being supplied to Univercells’ subsidiaries for use in the development and manufacturing of biological drug substances and (semi-)finished drug products, as well as for the supply of (semi-)finished drug products being manufactured by third parties on behalf of Univercells’ subsidiaries.
Moreover, you will ensure that materials and components are procured as per established specifications and from QA-approved/qualified/certified suppliers; and subcontracted development, manufacturing, and quality control operations are performed as per company and GMP requirements at approved third parties.
- 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.
REQUIREMENTS / QUALIFICATIONS
- 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