Quality & Compliance System Senior Specialist (Pharmaceutical)

TL;DR

Quality & Compliance System Senior Specialist (Pharmaceutical): Managing and improving the Quality Management System (QMS) to ensure GMP compliance with FDA and EU regulations with an accent on quality governance and regulatory alignment. Focus on implementing quality procedures, analyzing quality metrics, and resolving complex compliance issues within biopharmaceutical manufacturing.

Location: Parma, Italy. Must be based in or able to relocate to Italy. Hybrid setup with remote work options available.

Company

An international research-focused biopharmaceutical group with 90 years of experience operating in over 30 countries.

What you will do

• Develop and implement Quality Management Systems (QMS), including creating and updating procedures and documentation.
• Monitor and analyze quality data to identify trends and pinpoint areas for improvement.
• Prepare and submit periodic performance reports on the QMS to company management.
• Collaborate with cross-functional teams including production, engineering, and procurement to resolve quality issues.
• Investigate root causes of quality problems and develop corrective and preventative action plans.
• Promote a culture of quality and ongoing improvement throughout the site.

Requirements

• Degree in scientific subjects such as Chemistry, Pharmaceutical Chemistry and Technology, or Engineering.
• At least 5 years of experience in pharma or biopharma manufacturing within QA, Production, or Process Technology departments.
• Excellent knowledge of EU and FDA pharmaceutical guidelines.
• Specialized expertise in GMP compliance improvement processes.
• Fluent English (both written and spoken).

Nice to have

• Ability to establish strategies for managing multiple projects efficiently.
• Strong teamworking skills and constructive contribution to goals.
• Capacity to analyze technical issues and evaluate related risks.

Culture & Benefits

• Comprehensive healthcare programs and work-life balance initiatives.
• Competitive salary package including basic salary and performance bonuses.
• Flexible working arrangements and remote work options.
• Robust relocation support for eligible candidates.
• Tax assistance services for foreign colleagues.