Senior QMS & Compliance Leader — GMP/QA Systems (Remote)

Chiesi; Pordenone; Ibrido; EUR 70.000 - 90.000; Tempo pieno

Vantaggi offerti da questo lavoro

Healthcare programs

Work-life balance

Relocation support

Flexible working arrangements

Remote work options

Descrizione del lavoro

Chiesi in Pordenone, Italy is seeking a Quality & Compliance System Senior Specialist to lead and optimize the QMS ensuring GMP, FDA and EU compliance across the site. You will collaborate with cross-functional teams to drive quality improvements, manage inspections, training, and documentation, and report on QMS performance.

The role requires a degree in scientific subjects, at least 5 years in pharma/biopharma QA/Production/Process Technology, fluent English, strong analytical thinking and

Competenze

• Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering)
• Minimum 5 years of pharma/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

Mansioni

• Develop and optimize 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 governance

Quality data analysis

CAPA implementation

Root cause analysis

Analytical thinking

Effective communication

Stakeholder management

Cross-functional collaboration

GMP compliance

GxP knowledge

Formazione

Degree in scientific subjects

Descrizione del lavoro

Chiesi in Pordenone, Italy is seeking a Quality & Compliance System Senior Specialist to lead and optimize the QMS ensuring GMP, FDA and EU compliance across the site. You will collaborate with cross-functional teams to drive quality improvements, manage inspections, training, and documentation, and report on QMS performance.

The role requires a degree in scientific subjects, at least 5 years in pharma/biopharma QA/Production/Process Technology, fluent English, strong analytical thinking and