Global QMS Specialist

Discover International; Madrid; On-site; EUR 60,000 - 90,000; Full time

Job summary

Discover International seeks an experienced Quality Manager with an IT background to lead the rollout of a new Quality Management System at their Madrid site.

You will head a global team spanning CSV and quality digital systems, coordinating with IT, QA Operations, and Regulatory Affairs to align workflows and validation activities. Fluency in English is essential; Spanish is a plus.

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.

Responsibilities

• Support of new Labware Lims implementations.
• Support Labware Lims 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.
• Collaborate with IT, Quality Operations, and Regulatory Affairs to ensure system alignment
• Proactively identify risks and drive corrective and preventive actions (CAPAs)

Skills

IT background

Quality Management

LIMS knowledge

English communication

Education

Advanced degree in Chemistry/Pharmacy/Engineering

Tools

Labware LIMS

ERP

ELN

QMS software

Job description

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 Labware Lims implementations.
• Support Labware Lims 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.
• 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.