Senior QA Specialist

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

Are you looking for an exciting opportunity tojoin an international pharmaceutical company? In ALK, we are on a mission to improve the lives of people living with allergies, and we are seeking a person responsible for a wide range of Quality Assurance activities, providing quality oversight for Contract Manufacturing Operations (CMOs) involved in the manufacturing and packaging of ALK products. You will ensure that all activities are executed in compliance with company standards and applicable regulatory requirements.

As a trusted quality partner, you will actively contribute to the continuous improvement of our Quality Management System, driving best practices and helping to strengthen a culture of quality, compliance, and operational excellence across the organization.

Key responsibilities:

• Perform Quality Assurance activities associated with maintaining internal Quality Systems: Change control, Deviations, CAPA, APQR, etc.
• Review GMP technical and validation reports
  • Manufacturing and packaging processes.
  • Cleaning Validation/Equipment cleaning procedures.
  • Laboratory and manufacturing equipment
  • Facilities and Utilities with product contact.
• Provide quality support to technology transfer projects.
• Provide on-site guidance in the preparation of procedures and working instructions.
• Assist in providing resolution to GMP issues through identification of problem areas, refinement of systems, training and coaching of relevant personnel
• Provide QA support for regulatory submissions
• Prepare documentation for Material Review Board presentation and meetings
• Support QA Management as required
• Provide GMP quality expertise, advice and/or assistance across the organization as required

Candidate Requirements:

• Minimum of 5 years’ experience in the pharmaceutical/biotech industry and with a thorough knowledge of quality systems, GMP and regulatory requirements.
• University degree in Chemistry, Pharmacy, Biology or equivalent.
• Fluency in both written and spoken English and Spanish is essential.
• Thorough knowledge in Oral solids forms and technology transfer projects.
• Knowledge in sterile product regulations is valuable.
• Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, GMPs, regulatory issues, data integrity requirements.
• Strong interpersonal and leadership skills in dealing with a variety of cultures on non-routine matters in stressful situations, can navigate organisational complexity and ambiguity.
• Availability to travel approximately 30% of the time.