Quality Systems Leader

Insud Pharma; Sevilla; Presencial; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company in Sevilla is seeking a Quality Systems Leader. You will oversee the development and implementation of the global Quality Management System, ensuring compliance with international regulations. The ideal candidate has over 10 years of experience in the industry, strong leadership skills, and proficiency in digital QMS platforms. Competitive benefits and a collaborative work environment are offered.

Servicios

Permanent contract

Private health insurance

Continuous training and professional development

Formación

• Over 10 years of experience managing global quality systems.
• Deep knowledge of FDA regulations and ISO standards.
• Fluent in Spanish and English.

Responsabilidades

• Develop and maintain the QMS strategy aligned with regulations.
• Lead standardization of quality processes across manufacturing sites.
• Ensure readiness for internal and external audits.

Conocimientos

Leadership

Analytical skills

Intercultural communication

Project management

Educación

University degree in Chemistry, Pharmacy, Science, or Engineering

Herramientas

Digital QMS platforms (e.g., TrackWise)

Descripción del empleo

Position: Quality Systems Leader

Location: Spain (on-site)

Experience: Over 10 years in global quality systems management within pharmaceutical, biotechnology, or medical device industries

Company: INSUD PHARMA is a leading company in the pharmaceutical value chain, committed to innovation and sustainable development. Our Global Quality area ensures excellence and regulatory compliance across all processes and products worldwide. Are you 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, anticipate regulatory changes, and adapt processes to maintain excellence and compliance. Coordinate multidisciplinary teams and collaborate with IT to optimize digital quality tools.

Requirements:

• 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 project management skills.
• Languages: Fluent Spanish and English.

Benefits: Permanent contract, private health insurance, continuous training and professional development, 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.

Follow us: Follow us on LinkedIn and Instagram for more opportunities and news. #InsudPharma #GlobalQuality #InsudTalent

Commitment to equal opportunities: Insud Pharma is committed to equal opportunities and does not discriminate based on ethnicity, religion, age, sex, nationality, marital status, sexual orientation, gender identity, disability, or other personal circumstances, in accordance with Organic Law 3 / 2007.