Overview
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?
Responsibilities
* 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
Oversee the evolution of the global QMS, anticipating regulatory changes and adapting processes to maintain excellence and compliance. Coordinate multidisciplinary teams and collaborate with IT to optimize digital quality tools.
Qualifications
What do you need?
* University degree in Chemistry, Pharmacy, Science, or Engineering, with specific training in Quality.
* Over 10 years of progressive experience managing global quality systems in pharmaceutical, biotechnology, or medical device sectors.
* Deep knowledge of FDA 21 CFR, EudraLex, GxP regulations, and ISO standards (9001, 13485).
* Proven experience managing regulatory and third-party audits.
* Advanced skills in digital QMS platforms (e.g., TrackWise) and computer system validation.
* Strong analytical, leadership, intercultural communication, and complex project management skills.
* Languages: Fluent Spanish and English.
Benefits
* Permanent contract
* Private health insurance
* Continuous training and professional development plan
* Stable and collaborative work environment in a leading industry company
Selection process
* Initial contact via email or phone.
* Two formal interviews, combining virtual and on-site formats.
* Transparent and continuous communication throughout the process.
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Commitment to Equal Opportunities
Insud Pharma is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current regulations on the matter - Organic Law 3 / 2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.
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