Quality Manager, Mexico Facility

Position Summary The Quality Manager will be responsible for all aspects of quality for a cosmetic and OTC manufacturing facility in Tijuana, Mexico. Organize and supervise all quality employees on site including microbiology, quality control, quality assurance, validation and document control. This will involve managing resources, processes, procedures, and employee behavior. Ensure compliance with local quality regulations, maintenance of ISO ***** system and FDA 21 CFR 210 & 211 requirements. Direct, plan, organize and control the processes, procedures and activities related to quality management, to ensure compliance with standards and norms, as well as promote continuous improvement. Ability to speak fluently and communicate in Spanish and English is required. This position will report to the Director of Quality. Essential Tasks, Duties, & Responsibilities Oversee the daily functions of all quality laboratories. Review and approve documentation generated by those labs. Assign tasks to personnel in those labs, as necessary. Interact daily with production management to ensure quality systems are being followed in the manufacturing areas. Troubleshoot any quality issues and make recommendations on resolution of same. Oversee validation, calibration, IQ/OQ/PQ, OOS/CAPA, NCMR, deviations, writing and updating SOPs for processes that fall under the jurisdiction of quality and review and sign‑off on SOPs issued by functional areas throughout the facility for compliance with 21 CFR 211. Supervise and coordinate all quality‑related employees. Manage resources, processes, procedures, and employee behavior. Manage OTC stability program. Collaborate with engineering department and other functional areas in the review and issuance of SWI's (standard work instructions). Ensure Annual Product Review (APR) for drug products is completed by the end of the first quarter of following year. Conduct routine audits of manufacturing areas, laboratories, quality systems and generate reports with recommendations. Drive immediate resolution for non‑compliance. Co‑host FDA and 3rd party audits. Oversee and document training program for quality employees and in conjunction with HR track and monitor training of new hires by functional area supervisors in compliance with 21 CFR 211. Recommend additional training, education to assure progressive departmental advances. Provide decisive leadership, manage manpower requisitions, hire qualified personnel, and conduct employee reviews. Manage the daily quality operations in the Tijuana plant. Assure capable qualified processes for the manufacturing of the products and execute compliance with all applicable regulations for the products, including the US FDA 21 CFR 210, 211 and European/EU Regulations. Act as the delegate Quality Systems Management Representative as required. Ensure operational plans are aligned with business objectives. Execute compliance with 21 CFR 211 and ISO *****. Comply with safety, health and environmental control measures set out in the Company's RIT. Be able to accomplish all the above, and other assigned duties, by providing decisive and professional leadership; using all available resources; delegate as necessary. The responsibilities mentioned may vary and be increased based on the instructions of the Company's directors according to the Company's needs. Resumen de Posición El Gerente de Calidad será responsable de todos los aspectos de calidad de una planta de fabricación de cosméticos y OTC en Tijuana, México. Organice y supervise a todos los empleados de calidad en el sitio, incluyendo microbiología, control de calidad, garantía de calidad, validación y control de documentos. Esto implicará la gestión de recursos, procesos, procedimientos y el comportamiento de los empleados. Garantizar el cumplimiento de las normas de calidad locales, el mantenimiento del sistema ISO ***** y los requisitos de la FDA 21 CFR 210 y 211. Dirigir, planificar, organizar y controlar los procesos, procedimientos y actividades relacionadas con la gestión de la calidad, para asegurar el cumplimiento de las normas y normas, así como promover la mejora continua. Se requiere capacidad para hablar con fluidez y comunicarse en español e inglés. Este puesto reportará al director de calidad. Deberes y responsabilidades esenciales Supervisar las funciones diarias de todos los laboratorios de calidad. Revisar y aprobar la documentación generada por esos laboratorios. Asignar tareas al personal de esos laboratorios, según sea necesario. Interactuar diariamente con la gerencia de producción para asegurar que se sigan los sistemas de calidad en las áreas de fabricación. Solucionar cualquier problema de calidad y hacer recomendaciones para resolverlo. Supervisar la validación, la calibración, IQ/OQ/PQ, OOS/CAPA, NCMR, las desviaciones, la redacción y la actualización de los SOP para los procesos. #J-18808-Ljbffr