Our Client is a leading international company operating in Human Pharma and Animal Health industry.
For the Italian Office, we are searching a highly motivated and qualified
HEAD OF COMMERCIAL QUALITY
Reporting to the Country Managing Director, the candidate will be responsible for the implementation and maintenance of a regional quality management system for GDP/GMP and all health regulated activities, in compliance with all regulatory requirements.
The role covers both Human Pharma and Animal Health business areas and ensures that all relevant external (e.g. GMP, GDP) and internal requirements (e.g. policies and procedures) are implemented, monitored for performance and adherence, and improved, if required.
The candidate will be responsible for the successful conduct of authority inspections and the final decisions on strategic GMP/GDP relevant questions, in alignment with the management team. She/he will liaise with Global Quality functions, Supply Chain & Local Business as well as Suppliers and Wholesalers.
Main tasks and responsibilities:
- Management of the Commercial Quality Unit in line with the corporate strategy
- Ensure necessary interfaces to other departments (e.g. Supply Chain, IT, Compliance, Law, Sales)
- Cooperate, communicate with and provide information to other organizational units
- Manage Authority inspections (GDP and GMP)
- Budget realization and on-going monitoring responsibility
- Drive the implementation status/maintenance of the QMS (Quality Management System)
- Conduct employee reviews
- Ensure continuous improvement of processing and working steps along the responsible process chain and interface
- Continuously challenge the status quo, KPIs and processes to optimize measures and daily business.
Professional requirements and skills:
- Bachelor's degree in a scientific or healthcare-related field
- At least 8/10 years of work experience in a similar role in pharma, biotech, or other regulated industry, leading and successfully delivering on high-profile quality initiatives with senior executive leadership visibility
- Previous experience with global regulatory agencies, and a proven history of success in resolving regulatory compliance issues
- Strong command of English - spoken and written
- Strong communication skills
- Decisive, organized, and able to lead people
- Analytical and problem solving approach
- Excellent teamworking, ownership, cross-functional partnership ability
- Currently aspiring to senior management positions within a commercial quality environment