We are currently recruiting for A Senior Quality Manager, GxP, on behalf of our client, global pharmaceutical company to support local project in France. The position is based in Paris area.
* Manage the review and implementation of Quality Improvement/remediation plans
* Communicate quality and compliance risks as appropriate, to Country Management and for France to Pharmacien Responsable
* Monitor GMP, GxP Pharmacovigilance and compliance to regulations and the company’s procedures and communicate CAPAs and action plans to Country Management and Corporate Quality and for France to Pharmacien Responsable
* Act as Quality liaison between the local operational groups and Corporate Quality for GMP/GxP/PV functions and activities.
* Lead or support Specific projects related to French requirements on GxP, quality and for France Exploitant activities
* Ensuring that a quality management system (QMS) is implemented and maintained in compliance with local regulations and standards
* Manage self-inspection program and ensure independent audits are performed at regular intervals.
* Ensure systems are in place for initial and continuous training for all personnel concerned, according to training plans and regulations
* Organize and lead Quality Reviews and ensure oversight of product quality reviews
* Perform batch related activities, as apart of distribution (e.g. transport/temp reviews, batch release monitoring, complaints handling, recall management, shortage plans, etc)
* Ensure that tha company Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with relevant guidelines and local laws requirements, as responsibilities for France
* Master’s Degree pharmacy;
* Pharmacien Responsable interimaire is prefereable
* Extensive, hands-on Quality Assurance / Compliance and management experience in pharmaceutical/ biotech industry.
* Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance. (local French regulations, EMA) pertaining to GXP and Pharmacovigilance required
* Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.
* Strong leadership ability
* Exceptional communication and interpersonal skills
* Ability to work globally in a matrix environment
* Fluent French and English language required
This is permanent opportunity offering exciting projects and career profession. The company offers competitive salary package and career progression plan.
Please send your CV
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.