HireDiversity

Seine-Maritime, FR

QUALITY ASSURANCE SENIOR MANAGER-000006CY

Description

Val de Reuil plant is located in France 20kms from the Normandy City of Rouen. It's one of the main J&J consumer manufacturing site producing 200 millions pack per year (1/3 OTC drugs and 2/3 cosmetics )

Reporting to the Quality & Compliance Director and managing a team of 20 people ( managers and technicians), the position will be in charge of managing quality system for all activities against Regulatory requirement and J&J policies, standards and procedures.

KEYS RESPONSIBILITIES :
- Pharmaceutical responsibility : QP by interim ( pharmacist degree)
- Lead a team of Quality Managers in charge of Cosmetics and OTC ( release, reclamations and deviations)
- Management of internal audits in full respect of procedures and GMP
- Preparation and coordination of the Regulatory audits, representing the Quality & Compliance Director during this audits.
- Management of critical quality issues resolution and communication.
- Proactively identify quality and compliance gaps and ensure continuous improvement process through KPI and Management Action Plan and CAPA follow up
- Lead or participate to Corporate initiatives at the EAME (Europe Asia Middle East) regional level.
- Lead the implementation of the different QA projects / new WWSP (Worldwide Standard Procedures) on the manufacturing site.
- Build solid partnership with Operations, Production, R&D, Regulatory as well as other relevant stakeholders.

Qualifications


JOB REQUIREMENTS :

A pharmacist degree with 10 years experience in QA, QC or production in international pharma group is required for this position.An excellent knowledge of GMP and industrial environment is also required.
- In depth knowledge of GMP acquired trhough minimum 10 years experience in Manufacturing, Quality Assurance, Quality Control, Validation or Engeeniring in an international pharmaceutical product manufacturers. Knowledge of European Legislation for Marketing Authorizations and variations
- Fluent French. Fluent English.
- Proven experience in People management
- Strong communication skills and leadership track record, you are recognized for your Leadership and your sense of proactivity.

Primary Location:Europe/Middle East/Africa-France-Haute-Normandie-Seine-Maritime
Organization: Janssen Cilag S.A.S. (7825)
Job Function: Quality Control