Global QMS Specialist

Discover International; Madrid; Presencial; EUR 70.000 - 110.000; Jornada completa

Descripción de la vacante

Discover International in Madrid partners with a Global Pharmaceutical company to advance quality systems across human and animal health products. We are seeking an experienced Quality Manager with an IT background to develop and implement a new Quality Management System (QMS) and lead the team.

You will oversee Trackwise deployments, validation activities, CAPAs, and training, while ensuring compliance with FDA and other regulations.

Formación

• Advanced degree in Chemistry, Pharmacy, or related field.
• Fluent English; Spanish knowledge is a plus.
• Experience with Quality Management Systems.
• Minimum 3 years in pharma/biotech.

Responsabilidades

• Lead global QMS development and rollout.
• Oversee Trackwise implementations and validation.
• Manage CAPAs and regulatory alignment.
• Train and mentor junior staff.
• Collaborate with IT, Regulatory Affairs, and Quality Operations.

Conocimientos

Quality leadership

IT background

Team management

English fluency

Spanish desirable

Educación

Advanced degree in Chemistry

Advanced degree in Pharmacy

Herramientas

Trackwise

ERP systems

ELN

QMS software

Descripción del empleo

We are a partnered with a Global Pharmaceutical company who work with APIs, finished dosage forms, and branded pharmaceuticals, for both human and animal health. The company manufacture products for 100 countries, and their mission is to provide greater access to high need medicines across the globe. They have 18 state of the art facilities, located in more than 50 countries. This is for one of their mainstay sites, based in the heart of Madrid, they seek an experienced Quality manager with an IT background/skill set to help develop and implement their new QMS.

Role Overview:

This role sits in the Global Quality Systems team, and will play a major role in one of the companies most important projects. The role intends to develop, then roll out and implement their new Quality Management System. You have the opportunity to lead an experienced team, then grow and develop this in the long-run!

Responsibilities:

• Support of new Trackwise implementations.
• Support Trackwise and other enterprise systems (e.g., ERP, ELN, CDS, QMS)
• Participation in validation of the workflows
• Participation in the training and support of junior staff
• Participation in the training and technical support activities of key users at the sites.
• Leadership of a global team that cover CSV and Quality digital systems.
• Define and drive digital strategy for Quality systems.
• Full oversight of computerized system validation activities.
• Maintaining compliance with relevant regulatory standards, inc, FDA.
• Collaborate with IT, Quality Operations, and Regulatory Affairs to ensure system alignment
• Proactively 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 Quality Management Systems.
• Minimum of 3 years' experience in pharmaceutical or biotechnology industry.