Global Quality Assurance Specialist

Location: Gasteiz / Vitoria

In a few words

Position:
Global Quality Assurance Specialist

Location:

Spain (reporting to Turkey)

Experience:

2-5 years in Quality Management Systems within pharmaceutical/biotech industry

Want to know more?
At Insud Pharma, we operate across the entire pharmaceutical value chain, committed to innovation and sustainable development. Our Global Quality Management unit drives excellence worldwide, ensuring regulatory compliance and continuous improvement to safeguard human and animal health.

Are you ready to be a #Challenger and make a real impact in the pharmaceutical industry? Join us!

What are we looking for?
Support the implementation, maintenance, and continuous improvement of the global Quality Management System (QMS).
Participate in defining and executing the global QMS strategy aligned with FDA, EMA, and other international regulations.
Assist in harmonizing and standardizing key processes: CAPA, deviations, change control, audits, training, supplier management, and product release.
Prepare and support regulatory inspections and internal/external audits.
Manage digital QMS tools (Track Wise, LIMS), ensuring compliance with 21 CFR Part 11 and Eudra Lex Annex 11.
Monitor key performance indicators (KPIs) and prepare periodic reports to assess system effectiveness.
Implement risk management principles across quality processes.
Support the global audit program and supplier qualification.
Promote a strong quality culture and continuous training throughout the organization.

The challenge!
Oversee accurate documentation and record-keeping in compliance with regulations.
Coordinate audit activities and follow-up on findings to ensure effective closure.
Collaborate with global teams to align quality processes and standards.
Actively participate in digitalization and enhancement of quality management systems.

What do you need?
University degree in Chemistry, Pharmacy, Science, or Engineering.
2-5 years of progressive experience in Quality Management Systems within pharmaceutical, biotech, or medical device industries.
Deep knowledge of FDA 21 CFR, Eudra Lex, GMP, GCP, GLP, and ISO standards (9001, 13485).
Experience managing CAPA, deviations, change control, audits, and training.
Proficiency with digital QMS platforms (Track Wise Digital, LIMS) and system validation.
Fluent in English and Spanish.
Willingness to travel up to 10%.
Strong analytical skills, effective communication, and a proactive mindset for continuous improvement.
CSV training (GAMP
5) and familiarity with emerging technologies are a plus.

Our benefits!
Permanent contract
Professional development in a global, dynamic environment
Private health insurance
Continuous training and talent development programs
Opportunity to work on international projects with multicultural teams
How will the selection process be? ️
Initial contact by phone or email.
1 or 2 virtual or face-to-face interviews with HR and Hiring Manager.
Continuous communication about the process status.

Not the right fit?
Follow us on Linked In and Instagram to stay updated on new opportunities and news at Insud Pharma. We want you to be part of our community! #Insud Pharma #Challenger #Insud Talent

COMMITMENT TO EQUAL OPPORTUNITIES
At Insud Pharma, we promote an inclusive and diverse environment, ensuring gender equality and non-discrimination based on ethnicity, religion, sexual orientation, disability, or any other condition. We value talent and diversity as drivers of innovation and growth.