Site Quality Manager, Narita Site
Provide Quality leadership across the site organization.
Guarantees the quality and regulatory compliance of products developed, manufactured and distributed by the site in accordance with regulatory requirements and the Sanofi Group guidelines.
Participate in AMEA and Global Quality meetings, gather and exchange information with each site.
Knowledge And Skills:
Knowledge: GxP and health-related regulations, Quality Assurance, Quality Control, Quality risk analysis, Quality systems, Audit, Validation (process, cleaning, analytical), Regulatory and company requirements.
Knowledge of employment law and guideline.
Skill: Communication skill (Japanese, English), Decision making, Lead teams, Leadership & Assertiveness skills, Problem solving, task/project management.
Formal Education, Experience Required:
Doctor of Pharmacy, preferably advanced degree or equivalent practical experience. Background in pharmaceutical science, chemicals, science, and bioscience.
At least 10 years professional experience in Quality management in pharmaceutical industry or equivalent practical experience; with a good mix of leadership, technical and operational experience.
Knowledge And Skills Desirable But Not Essential:
Qualified auditor, microanalysis, PTC (Pharma), analytical equipment, Pharmacopeia (JP, EP, USP etc.), analytical transfer
Skill: Networking capability: internal and/or external, Business partnering, Negotiation and Influential skills, Develop people
PRINCIPAL DUTIES AND RESPONSIBILITIES
MAJOR DUTIES & RESPONSIBILITIES
Prepare Dept. policy. Ensures the implementation and management of quality systems in the site
-a control system and release of materials and products handle
-the deviation and change control management
-corrective and preventive actions
-organization of self-inspections
-the compliance with regulatory and company requirements
-the documentation system
-site quality training system
Ensure product supply to the market
-Management of third-party suppliers
Quality system integration toward Sanofi QMS
-Site audits and inspections
-Global document implementation
Ensure continuous improvement in the Department
Maximize synergy of Quality activities among Sanofi global network/ CHC IA
KPI management of contribute to site priority, site quality roadmap
Enhancement of the quality program of the site
Ensure HSE at Narita plant
-Realize policies and guidelines with regard to working conditions in the Department
-Comply with HSE policies and guidelines
-Ensure safety culture in the Department
Drive and commit SMS(Sanofi Manufacturing System) activity in accordance with SMS roadmap
Allocate and control the best member to appropriate position for the group, and develop the member's competence
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.