System Quality Assurance Manager

il y a 5 jours

Paris, France PathoQuest Temps plein

**Who We Are**:
PathoQuest is a specialized CRO, a spin-off of Institut Pasteur, whose purpose is to study, research and identify pathogens by High Throughput Sequencing for the Quality Control of pharmaceutical products of biological origin, both in France and abroad. PathoQuest offers innovative biotech companies worldwide a complete expert service from sample receipt to the production of certificates of analysis. Its tests are based on proprietary sample processing protocols, a high-throughput sequencing platform and specialised bioinformatics analysis pipelines. Currently in a scale-up phase, we have about 50 employees in France and the United States.

**Your Role**:
Reporting directly to the Chief Pharmaceutical Officer, your expertise will enable you to support our rapid growth in the testing of biological products. Your mission is to set up and maintain a quality system in connection with all the company’s activities to ensure that the activities comply with the required standards. You will also be in charge of the pharmaceutical responsibility in back-up of the Pharmacist in charge (Interim Pharmacist in charge).

**Your responsibilities**:

- Implement the quality assurance policy
- Prepare and lead customer audits
- Train internal auditors
- Define and monitor annual internal and external audit plans
- Monitor the management and approval of suppliers and subcontractors according to their criticality
- Contribute to the preparation of management reviews
- Implement the business continuity plan
- Set up and maintain indicators for monitoring the quality of services provided
- Suggest improvements and/or developments in the field of quality
- Organize the Quality Management System and its compliance,
- Ensure the proper management of documentation
- To follow in particular the CAPA and to sensitize the personnel on this follow-up,
- Raise awareness and inform the company about the quality approach
- Develop quality assurance tools

**Your profile**:

- Pharmacist, you have 5 years experience in system quality assurance & compliance / supplier quality assurance,
- You are eligible for registration in section B,
- You have experience with biological products or in the field of biotechnology or quality control,
- As the position is cross-functional between Paris and the United States and in order to interact with the auditors, you have a fluent level of English
- You are familiar with GMP standards
- You have experience in operational QA (optional)

**Your expertise**:

- You like innovation and you want to participate in the development of a company
- Ability to lead cross-functional projects
- Leading multidisciplinary teams
- Ability to lead change
- Pragmatism, discernment, assertiveness
- Methodical, rigorous and autonomous

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