Suppliers/Vendors Quality Specialist

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!”

Univercells SA brings together a group of Belgian and global biotech affiliates working together under a common mission (the “Group”). Each division of affiliates operates a different part of the healthcare value chain, through a distinct business model:

Exothera is a contract research, development, and manufacturing organization (CRDMO) dedicated to viral vector and nucleic acids production. As a technology-driven company, Exothera provides best-in-class bioprocessing expertise that capitalizes on the best and most innovative manufacturing technologies developed within the Univercells group. The company delivers accelerated discovery services and process development/optimization to rapidly reach GMP clinical and commercial production of viral vectors and nucleic acids. 

Unizima delivers international project management of technology transfer, alongside operational support services (quality, supply chain, digital) and bioproduction training programs, as well as care centers and diagnostics surveillance centers.

Quantoom Biosciences is reinventing mRNA production by developing an mRNA production platform (NfinityTM) from sequence up to mass production.

RLM Consulting thanks to a substantial knowledge of the pharmaceutical industry and a strong scientific background, RLM Consulting provides international regulatory affairs support at all stages of product development, from discovery research through preclinical and clinical testing, up to and beyond submission of the dossier for marketing authorization.

We deliver excellence and strive for innovation thanks to collaborative teams of passionate change-makers. We are driven by 5 core values in everything we do: Accountability, Continuous Improvement, Teach & Lead, Integrity, and Team spirit.

MISSION

The Suppliers/Vendors Quality Specialist has the responsibility for quality oversight of suppliers to ensure that Univercells’ affiliates are being supplied with materials and services in compliance with the established specifications thereof. 

Therefor, the role is responsible for ensuring that

• Initial supplier qualification is being performed including audits if required.
• Continuous supplier oversight is being performed by handling of complaints and change requests
• Periodic supplier (re-)evaluation is being performed
• Quality responsibilities between suppliers or services providers and UNVC are confirmed in Quality Agreements
• Supplier Change Notifications are well managed

RESPONSIBILITIES

As Suppliers/Vendors Quality Specialist , you will be responsible to:

1/ Supplier Qualification

• Perform initial and periodic supplier qualification activities as per internal quality procedures : send of the corresponding questionnaires, document the assessment, propose and document conclusions. 
• Establishment and negotiaciation of quality assurance agreements with the suppliers : confirm QAA template and valuable clauses, negotiate clauses and edit QAA by Suppliers
• Involved in supplier-related aspects of new material introduction – Participate to the assessment of the material (service) criticality level
• Manage the audits, if required, of the suppliers (initial, routine, qualification, for cause audits) : document the auditor selection, document the agenda confirmation, assess the report, confirm the supplier capa plan definition 
• Maintain the list of qualified suppliers (scope, status, life cycle)

2/ Supplier Oversight

• Perform periodic suppliers’ quality reviews : update KPIs related to Suppliers performance, propose corrective actions if even. 
• Manage Supplier Change Notifications as applicable procedures (initiation of the changes, contacts with affiliates, reconciliation and closure) and propose corresponding actions (e.g. , requalification, …)
• Consolidate and send supplier complaints and manage the follow-up with the concerned affiliates

REQUIREMENTS / QUALIFICATIONS

• Scientific background (Pharma, Engineer, Bio or Chemicals, …)
• Minimum 5 years of experience ideally in Quality management and/or Supply chain management
• Quality systems and qualification process knowledge / GxP - ISO standards knowledge / Audits process knowledge: able to analyze audit report and findings responses.
• Good verbal and written communication skills in English and in French
• Structured and documentary rigor
• Good negotiator and appetite for details but able to decide and conclude (Quality Agreements management)

OUR OFFER

We offer a long-term contract (CDI), a competitive salary package including many interesting compensations and benefits (including the possibility to do regular homeworking), ad-hoc training to develop hard and soft skills, and the possibility of evolution in an international, dynamic, and fast-growing company.

Is this function of Suppliers/Vendors Quality Specialist  appealing to you? Do you want to work in a great and motivated team? Let’s meet! Apply!.