Global QA Lead – GMP, Tech Transfer & CMO Oversight

ALK; Madrid; On-site; EUR 45,000 - 65,000; Full time

Job summary

ALK is seeking aQuality Assurance professional to oversee QA activities for Contract Manufacturing Operations, ensuring compliance with GMP and regulatory standards. You will contribute to the improvement of the Quality Management System and support technology transfer, change control, deviations, CAPA, and regulatory submissions.

The ideal candidate has 5+ years in pharma/biotech, degrees in chemistry/biology/pharmacy, and fluency in English and Spanish. Travel about 30% is expected.

Qualifications

• 5+ years in pharma/biotech with GMP and regulatory knowledge.
• Degree in Chemistry, Pharmacy, or Biology.
• Fluent in English and Spanish.
• Experience with oral solids and tech transfer projects.
• Knowledge of sterile product regulations is valuable.
• Expertise in interdisciplinary pharmaceutical sciences, analytical chemistry, microbiology, GMPs, regulatory issues, data integrity.
• Strong interpersonal and leadership skills across cultures.
• Willingness to travel ~30%.

Responsibilities

• QA activities maintaining internal quality systems (change control, deviations, CAPA, APQR).
• Review GMP technical and validation reports.
• Support technology transfer projects.
• Provide on-site guidance for procedures and working instructions.
• Resolve GMP issues through problem identification, system refinement, and training.
• Provide QA support for regulatory submissions.
• Prepare documentation for Material Review Board presentations.
• Support QA Management as required.
• Provide GMP quality expertise across the organization.

Skills

Quality Assurance

GMP compliance

Regulatory knowledge

CAPA

Change control

Deviation management

Analytical chemistry

Cross-cultural leadership

Training and coaching

Documentation control

Education

University degree in Chemistry

Pharmacy degree

Biology degree

Tools

Quality Management System

Regulatory software

Job description

ALK is seeking aQuality Assurance professional to oversee QA activities for Contract Manufacturing Operations, ensuring compliance with GMP and regulatory standards. You will contribute to the improvement of the Quality Management System and support technology transfer, change control, deviations, CAPA, and regulatory submissions.

The ideal candidate has 5+ years in pharma/biotech, degrees in chemistry/biology/pharmacy, and fluency in English and Spanish. Travel about 30% is expected.