Quality & Compliance System Senior Specialist

Overview

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.

Retribuzione / Benefits comprehensive healthcare programs

work-life balance initiatives

relocation support

competitive salary

flexible working arrangements

remote work options

Responsabilità 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

Requisiti fondamentali 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