Senior Quality Assurance Manager - Pharmaceutical Industry

beBeequality; Madrid; Presencial; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A global quality systems organization is seeking a Quality Assurance Manager based in Madrid, Spain. This role involves leading LabWare LIMS implementations and ensuring compliance with regulations such as FDA standards. The ideal candidate will have an advanced degree in a relevant field and a minimum of 6 years' experience in the pharmaceutical or biotechnology sectors, along with excellent English communication skills.

Servicios

Competitive remuneration

Clear growth and development plan

Global teamwork

Meaningful contribution to improving lives

Formación

• Advanced degree in a relevant field is required.
• 6+ years of experience in the pharmaceutical or biotechnology industry.
• Proficient in English; Spanish is a plus.

Responsabilidades

• Lead new LabWare LIMS implementations.
• Manage compliance with regulatory standards.
• Collaborate with IT and quality operations.

Conocimientos

Quality assurance

Regulatory compliance

LabWare LIMS

Communication in English

Educación

Advanced degree in Chemistry, Pharmacy, or Chemical Engineering

Herramientas

LabWare LIMS

ERP systems

ELN

CDS

QMS

Descripción del empleo

We are seeking a skilled Quality Assurance Manager to join our team. As a key member of our Global Quality Systems team, you will play a crucial role in the development and implementation of our new Quality Management System.

This is an excellent opportunity for a seasoned professional with experience in quality assurance and IT to make a significant impact on our organization's success.

Responsibilities

• Lead and manage new LabWare LIMS implementations.
• Manage LabWare LIMS and other enterprise systems (e.g., ERP, ELN, CDS, QMS).
• Lead a global team that covers CSV and Quality digital systems.
• Define and drive digital strategy for Quality systems.
• Oversight of computerized system validation activities.
• Maintaining compliance with relevant regulatory standards, including FDA.
• Act as Subject Matter Expert during regulatory audits and local inspections.
• Collaborate with IT, Quality Operations, and Regulatory Affairs to ensure system alignment.
• Identify risks and drive corrective and preventive actions (CAPAs).

Qualifications

• Advanced degree in Chemistry, Pharmacy, Chemical Engineering, or related field.
• Excellent English communication skills, and Spanish proficiency is a plus.
• Experience working with LabWare LIMS and other enterprise systems (e.g., ERP, ELN, CDS, QMS).
• Minimum of 6 years' experience in pharmaceutical or biotechnology industry.
• Strong understanding of EU and FDA regulations for pharmaceutical R&D, manufacturing, and distribution.
• 15% Travel requirement.

Benefits

• Competitive Remuneration.
• Clear growth and development plan.
• Work within a global team.
• Make a meaningful contribution to improving lives globally.