Santé

2 septembre 2020

Deputy Quality Assurance Director (F/M)

Our client is a pharmaceutical company at clinical stage developing innovative drugs. 

To ensure the continuity of its development, they are looking at recruiting a Deputy Quality Assurance Director (M/F) based in their headquarters in central Paris. 

Reporting directly to the Quality Director, you will be in charge of: 

• Developping and improving quality management systems based on current best practices in the industry; 
• Guaranteeing the company’s quality compliance in pre and post AMM programs; 
• Managing the auditing function by developing and managing detailed audit plans for all involved partners; 
• Developping and implement tools for quality risk management; 
• Ensuring the high level of the vendor selection, qualification and monitoring process; 
• Managing and trend the deviation process; 
• Managing CAPA commitments to ensure timely completion of the outlined tasks and effectiveness; 
• Investigating and address identified compliance and quality issues and develop solutions to correct known and potential compliance and quality concerns; 
• Supporting QA activities, i.e. conducting international audits, maintaining quality databases and performing trend analysis, reporting metrics, developing and updating SOPs, specifications, policies and/or other quality documents as needed. 
• Supporting market in launching planning, preparation and execution to optimize commercialization path. 

You hold a Bachelor degree in Engineering, Chemistry, Biological Sciences or in related fields, with 10+ years of experience acquired in a pharmaceutical company, in a quality assurance role, analytical testing or engineering including 5 years in a related management role. 

You have a significant experience of EMA and FDA inspections and you hold ASQ Auditor certification (ASQ Quality Engineer preferred). 

You are very comfortable in a small company and in a fast-paced environment. 

Agile and flexible, you are able to adjust your workload according to changing priorities. 

You speak English fluently, and you have a strong experience in international project management. 

To end with, you have an experience in CRA or in CRO. 

Localisation : Paris

Référence de l’annonce : ALA20009

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