Gerente de Aseguramiento de la Calidad - Cumplimiento

Catalent

Buenos Aires, Argentina Onsite Quality Assurance Methods ES

About this role

En Catalent estamos buscando un/a Gerente de Aseguramiento de la Calidad - Cumplimiento para nuestra planta ubicada en Loma Hermosa, Buenos Aires.

Principales Responsabilidades:

Liderar y gestionar auditorías internas, corporativas, externas y de proveedores con impacto en GxP, así como inspecciones regulatorias.

Administrar los sistemas de Calidad: CAPA, QCA, documentación GxP y entrenamiento GxP.

Coordinar y supervisar los programas de validación de procesos productivos, limpieza, calificación de equipos, servicios, áreas y validación de sistemas informáticos.

Gestionar el programa de Integridad de Datos.

Desarrollar y mantener Acuerdos de Calidad con proveedores y clientes, asegurando una comunicación efectiva.

Alinear las operaciones del área con políticas corporativas, estándares globales y normativas regulatorias vigentes.

Aprobar y autorizar documentación del área, definiendo jerarquías documentales y niveles de revisión.

Identificar, evaluar y mitigar riesgos de calidad, reportando a la Dirección de Calidad.

Definir indicadores de gestión, monitorear resultados y reportar desempeño del área.

Administrar el presupuesto del sector y proponer inversiones estratégicas.

Liderar, desarrollar y potenciar al equipo, promoviendo una gestión participativa y un uso eficiente de los recursos.

Formación y experiencia:

Profesional Farmacéutico, Bioquímico, Químico o afín.

Mínimo 10 años de experiencia en la industria farmacéutica.

Al menos 5 años de experiencia en posiciones de liderazgo en áreas de Calidad.

Inglés avanzado (lectura y escritura).

Sólido conocimiento en normativas cGMP y regulaciones internacionales (21 CFR 210, 211 y Part 11, ICH, USP, BP, EP).

Manejo de herramientas informáticas y sistemas de gestión de calidad.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.