Quality & Compliance System Senior Specialist

Chiesi; Siena; Ibrido; EUR 70.000 - 110.000; Tempo pieno

Vantaggi offerti da questo lavoro

Healthcare programs

Work-life balance

Relocation support

Flexible working

Remote work options

Descrizione del lavoro

Chiesi in Siena, Italy, seeks a Quality Management System Senior Specialist to lead QMS development and ensure GMP, FDA and EU compliance across the site.

You will partner with production, engineering and procurement to drive improvements, manage inspections, CAPA, and reporting, while promoting a culture of quality with robust documentation and training.

Competenze

• Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering).
• At least 5 years of pharmaceutical/biopharmaceutical experience in QA, Production, and Process Technology.
• Excellent knowledge of EU and FDA pharmaceutical guidelines.
• Specialized expertise in GMP compliance improvement processes.
• Fluent English (written and spoken).

Mansioni

• Develop and implement QMS processes, procedures, and documentation to meet quality standards.
• Monitor and analyze quality data, identify trends, and drive improvement actions.
• Prepare periodic QMS performance reports for management.
• Collaborate with production, engineering, procurement and other functions to resolve quality issues.
• Investigate quality problems, identify root causes, and implement CAPA.
• Govern and promote a culture of quality and continuous improvement across the site.
• Share best practices and ensure activities comply with company procedures.

Conoscenze

QMS development

GMP knowledge

FDA/EU guidelines

CAPA implementation

Root cause analysis

Cross-functional collaboration

Analytical thinking

Communication

Quality data analysis

Quality management

Formazione

Degree in scientific subjects

Descrizione del lavoro

In this role you will lead and optimize the Quality Management System to ensure GMP, FDA and EU compliance across the site. You will partner with cross-functional teams to drive quality improvements, manage inspections, training, and documentation, and report on QMS performance. You will enable a culture of quality and continuous improvement, shaping robust processes for materials, manufacturing, and release specifications. This is a chance to contribute to a globally recognized biopharmaceutical group focused on sustainable health outcomes.

• comprehensive healthcare programs
• work-life balance initiatives
• relocation support
• flexible working arrangements
• remote work options
• Develop and implement QMS processes, procedures, and documentation to meet quality standards
• Monitor and analyze quality data, identify trends, and drive improvement actions
• Prepare periodic QMS performance reports for management
• Collaborate with production, engineering, procurement and other functions to resolve quality issues
• Investigate quality problems, identify root causes, and implement corrective and preventive actions (CAPA)
• Govern and promote a culture of quality and continuous improvement across the site
• Share best practices and ensure activities comply with company procedures
• Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering)
• At least 5 years of pharmaceutical/biopharmaceutical experience in QA, Production, and Process Technology
• Excellent knowledge of EU and FDA pharmaceutical guidelines
• Specialized expertise in GMP compliance improvement processes
• Fluent English (written and spoken)
• Strong teamwork and cross-functional collaboration
• Analytical thinking with ability to assess technical issues and propose shared solutions
• Effective communication and stakeholder management
• QMS development and governance
• Quality data analysis and trend identification
• Root cause analysis and CAPA implementation

Quality & Compliance System Senior Specialist • siena, toscana, it