About the Role

Our client is seeking a highly experienced and strategic Gerente de Aseguramiento de Calidad Farmacéutica (QA Manager) to lead their quality assurance initiatives. This pivotal role will be based in Chihuahua, Chihuahua , and will be responsible for ensuring that all pharmaceutical products meet stringent quality standards and comply with regulatory requirements. The idóneo candidate will have a deep understanding of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant quality systems. This position offers an exciting opportunity to shape the quality culture within a growing pharmaceutical organization and contribute to the delivery of safe and effective medicines. You will be instrumental in maintaining the integrity and reputation of our client's products by implementing and overseeing robust quality control processes. We are looking for a leader with a proven track record in quality management within the pharmaceutical industry, capable of driving continuous improvement and ensuring operational excellence. Your strategic vision and hands-on approach will be key to success.

Key Responsibilities

Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with GMP, GDP, and other applicable regulations. Oversee all quality assurance activities, including batch record review, deviation management, change control, and CAPA (Corrective and Preventive Actions). Lead and mentor the QA team, fostering a culture of quality and continuous improvement. Conduct internal audits and host regulatory inspections (e.g., COFEPRIS, FDA, EMA). Manage supplier qualification and auditing processes to ensure the quality of raw materials and components.



Review and approve validation protocols and reports for manufacturing processes and equipment. Investigate product quality complaints and implement appropriate corrective actions. Ensure compliance with all national and international pharmaceutical regulations. Monitor quality metrics and provide regular reports to senior management on the state of quality.

Requirements

Bachelor's degree in Pharmacy, Chemistry, Engineering, or a related scientific field. Master's degree preferred. Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry, with at least 3 years in a management role. In-depth knowledge of GMP, GDP, ICH guidelines, and regulatory requirements. Proven experience in developing and implementing QMS. Strong leadership, management, and team-building skills. Excellent analytical, problem-solving, and decision-making abilities. Proficiency in audit management, deviation investigation, and CAPA implementation. Effective communication and presentation skills, both written and verbal. Experience with regulatory inspections and submissions.

Benefits

Our client offers a highly competitive salary commensurate with experience and a comprehensive benefits package. This includes health, dental, and vision insurance, a retirement savings plan, and generous paid time off. You will have the opportunity to work in a challenging and rewarding role, contributing significantly to the company's success. Professional development and continuous learning are strongly encouraged, with opportunities for further training and participation in industry conferences. The position offers significant autonomy and the chance to lead impactful quality initiatives within a reputable organization in Chihuahua, Chihuahua . Join a team dedicated to excellence and making a difference in pharmaceutical quality.

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📌 Gerente de Aseguramiento de Calidad Farmacéutica (QA Manager) (Chihuahua)
🏢 Placements24
📍 Chihuahua