Sanofi is looking for a CHC Quality Head Russia.
JOB PURPOSES:
Lead and manage the implementation and maintenance of the CHC Affiliate Quality System (covering GxP and health-regulated activities) across the Russian CHC Commercial organization, to ensure that quality processes and activities in scope are executed in compliance with the CHC Global Quality standards and applicable GxP regulatory requirements
Secure delivery of safe, efficient, quality CHC products, information & services to ensure patients / customers safety and act as Quality Business partner to support business priorities
As Responsible Person, ensure GDP compliance of wholesale distribution activities within the CHC affiliate marketplace
Focal point of contact in front of the Competent Authorities for any CHC product quality / technical, GMP and GDP-related matter
KEY ACCOUNTABILITIES:
Define, implement, manage and control the CHC Affiliate Quality system across the CHC commercial office, in compliance with CHC Global Quality Policy and standards and with local applicable regulatory requirements
NECESSARY KNOWLEDGE & EXPERIENCE:
Practical proved experience in Quality System Management in Health regulated industry. Knowledge & experience in Medical, Clinical or in pharmacovigilance domain. Practical GDP experience
Education level: Higher, a degree in pharmacy or pharmaceutical technology
Working experience: 5+ years in quality control in pharmaceutical industry, including in GDP and GMP
English: fluent
Managing the team
Advanced level of knowledge (theoretical):
GxP (namely GMP, GDP) and health regulated regulations
Quality Systems / Affiliate Quality management (commercial organization)
Continuous improvement management
Quality risk analysis / Quality risk management
COMPETENCY REQUIREMENT:
(Soft / Lead skills at advanced level)
Act for change with agility
Commit to customers
Cooperate transversally
Strive for results
Decision making
Problem solving
Business Partnering
Communication skills (oral & written, English)
Internal and external networking capability
Project management skills
Leadership and assertiveness skills
Negotiation and influential skills.
