Quality Manager ISO9001:2015 Manufacturing in Life Sciences

Scipio Bioscience is a start-up company developing an innovative solution for sample preparation in single-cell RNA sequencing (scRNA-seq). This solution, based on a kit format and complemented by a SaaS product for the analysis of the data from this kit, will allow decentralized and flexible sample preparation in all laboratories and will provide the means for new advances first in transcriptomics but also in all fields of clinical and fundamental research. Hosted in the heart of Paris (Institut du Cerveau, Pitié Salpêtrière), it has a multidisciplinary team of about twenty people and is supported by a recent €6 million fundraising campaign.

Location: Paris, France
Salary: To be negotiated
Starting Date: ASAP

We are looking for highly diligent candidates with excellent attention to detail for the role of Quality Manager. Quality Manager will be responsible for monitoring and evaluating internal and external processes, examining products to determine their quality, and engaging with customers and gathering product feedback, among other duties.

As a Quality Manager, you will coordinate the activities required to meet the quality standards set for Scipio Bioscience Products. You will ensure that this quality is consistent and meets both external (Customers) and internal requirements. Your role is concerned with monitoring and advising on the performance of the quality management system, producing data and reporting on performance, measuring against set standards.

 

Missions & responsibilities

  • You will have to implement from scratch the Quality Management System (QMS) to the ISO9001:2015 or most recent release of standards.
    • Define, establish and maintain our Quality procedures and standards
    • Provide training, tools, and techniques to enable others to achieve quality standards
    • Write the Quality Manual with goals as defined with the Management
    • Define and write processes and quality procedures in collaboration with operating staff
    • Select and coordinate the implementation of software solution(s) for electronic document management and quality management
    • Manage documents quality: SOPs, MOPs, Quality and Supply agreements, …
    • Organize and lead periodic management meetings, lead approaches to define efficient KPIs for our organization and context
    • Report on QMS performance and conformance
    • Organize and lead non conformity and corrective action processes
    • Lead internal audits

 

  • Related to the Products manufactured by the company:
    • Implement methods to inspect, test, and evaluate products and production equipment
    • Participate in the definition of the QC strategy
    • Ensure that products adhere to quality standards
    • Prepare reports by collecting, analyzing, and summarizing data
    • Work according to deadlines for the delivery of products
    • Perform detailed and recorded inspections (or oversee inspections) of final products so the products are up to industry and company standards
    • Ensure that Products meet requirements,
    • Ensure products are designed with adherence to legal and safety standards,
    • Identify risks and opportunities for Product quality

 

Qualifications and required skills

  • Relevant skills to the technology, with a Master’s degree in biology, is required with ideally a specialty on Quality Management
  • Certification for Quality Management
  • Significant experience in managing quality in manufacturing in a similar environment (life sciences, diagnostics, med devices)
  • Experience of implementation of an ISO9001 QMS is a serious advantage
  • Experience of ISO13485 will be an asset
  • Attention to detail
  • Analysis, critical-thinking and problem-solving skills to review systems, find flaws and pose solutions to those flaws
  • Interpersonal skills
  • Experience with interfacing with sub-contractors
  • Ability to handle stress
  • Ability to operate under deadlines while still meeting standards
  • Fluency in English and French is required.

Location

The job is based in Paris and includes remote working (home office) whenever possible.

The candidate will have to travel in France and abroad (e.g., for suppliers audits…).

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