Validation Manager

• Eysins, Switzerland


• Full-time

Company Description

Quotient is a commercial-stage diagnostics company committed to increasing efficiencies and improving patient care through the provision of innovative tests within established markets. With an initial focus on blood grouping and donor disease screening (transfusion diagnostics), Quotient is developing MosaiQ™, its next generation automation platform to address the comprehensive needs of the global transfusion diagnostics market. Once approved for sale, MosaiQ™ will be the first fully automated solution for blood grouping, quickly and comprehensively characterizing both donor and patient blood, improving patient outcomes and eliminating the need for expensive and time-consuming manual testing. MosaiQ™ will also undertake all mandated serological disease screening tests required for donor blood. Quotient has over 30 years of experience developing, manufacturing and commercializing transfusion diagnostic products. The company’s operations are based in Switzerland, Scotland and the US. We are now recruiting for our next:

Job Description

The Validation Manager will be responsible to define and set strategies for all validation and qualification activities associated with the introduction of this product through design/development, technical transfer, manufacturing and licensure. More specifically this role entails:

• Develop specific project alidation planning/scheduling documents with respect to new product introduction and Facility Design


• Determine risk based validation strategy with respect to the validation standards


• Ensure delivery of validation projects in line with the budget


• Define, manage and implement all validation and qualification activities for new and existing equipment and systems


• Be involved in internal and external audits, act as Subject Matter Expert


• Act as the Interface between departments to ensure validation issues communicated effectively and ensure key relationships


• Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation practice (GDP) and appropriate regulatory requirements

Qualifications

• Engineering or Science degree (Pharmaceutical/Biotechnologies…)


• Minimum 5 years experience working in a Validation department in a GMP environment


• Minimum 5 years experience in management of teams involving internal and external resource ensuring delivery to schedule and budget


• Experience in managing validation aspects of new product introduction in a medical device


• Significant specialist knowledge of ISO 13485 and 21 CFR 600 & 820 standards


• Good knowledge of Six Sigma / Lean Manufacturing, Statistical Analysis and Computerised Systems Validation is an asset


• Good communication skills and ability to manage and train teams


• Ability to work in an international team in a fast-paced changing environment


• Effective time management and good organisational skills


• Excellent spoken and written English. French is an asset

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