Global QMS Leader: Regulatory Compliance & Audits

Insud Pharma; Madrid; On-site; EUR 90,000 - 130,000; Full time

Job summary

Insud Pharma in Madrid seeks a Global Quality Assurance Manager to lead the enterprise-wide QMS strategy and drive continuous compliance across sites worldwide. You will oversee regulatory readiness, CAPA, change control, audits, and supplier quality in a highly regulated pharmaceutical environment.

The role requires a strategic, hands-on leader with 10+ years in quality management within pharma/biotech or medical devices.

Qualifications

• University degree in Chemistry, Pharmacy, or another relevant Science/Engineering discipline.
• Fluent English is required.
• Spanish will be considered an asset.
• Minimum 10+ years of progressive experience in Quality Management Systems within the pharmaceutical, biotechnology, or medical device industries.
• Proven experience interpreting regulatory requirements (FDA/EMA) and leading QMS initiatives.

Responsibilities

• Develop, implement, and maintain a comprehensive global QMS strategy aligned with regulatory requirements and industry best practices.
• Ensure the QMS is fully compliant with US FDA, EU regulations, and other applicable global requirements.
• Oversee the full QMS lifecycle, including design, implementation, maintenance, and continuous improvement.
• Lead global initiatives to harmonize and standardize quality processes across manufacturing, R&D, and commercial sites.
• Act as a key subject matter expert during internal and external audits, including FDA and EMA inspections.
• Collaborate with IT and QMS software owners to ensure digital tools support 21 CFR 11 and EudraLex Annex 11 requirements.

Skills

Fluent English

Education

University degree in Chemistry, Pharmacy or related Science/Engineering

Job description

Insud Pharma in Madrid seeks a Global Quality Assurance Manager to lead the enterprise-wide QMS strategy and drive continuous compliance across sites worldwide. You will oversee regulatory readiness, CAPA, change control, audits, and supplier quality in a highly regulated pharmaceutical environment.

The role requires a strategic, hands-on leader with 10+ years in quality management within pharma/biotech or medical devices.