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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