In a few words
Position:
Quality Systems Leader
Location:
Spain (on-site)
Experience:
Over 10 years in global quality systems management within pharmaceutical, biotechnology, or medical device industries
Want to know more?
INSUD PHARMA is a leading company in the pharmaceutical value chain, committed to innovation and sustainable development. Our Global Quality area is key to ensuring excellence and regulatory compliance across all our processes and products worldwide.
Ready to lead global quality?
What are we looking for?
* Develop, implement, and maintain the global Quality Management System (QMS) strategy aligned with business objectives and international regulations (FDA, EMA, ISO).
* Lead the harmonization and standardization of quality processes (CAPA, deviations, change control, audits, training, suppliers) across all manufacturing sites and business units.
* Act as the primary expert during internal and external audits, ensuring readiness and compliance with regulatory inspections.
* Oversee the management and validation of digital QMS platforms, ensuring compliance with electronic records regulations.
* Establish key performance indicators to monitor system performance and promote continuous improvement.
* Integrate risk management principles throughout quality processes.
* Foster a strong quality culture through training programs and leadership of specialized teams.
The challenge!