About the Role

Our client, a reputable pharmaceutical company committed to delivering high-quality medicines, is seeking an experienced Quality Assurance Manager to lead their QA operations. This is a fully remote position, offering the flexibility to manage quality systems and compliance from anywhere. The primary responsibility of this role is to ensure that all pharmaceutical products meet stringent quality standards and regulatory requirements throughout their lifecycle. The ideal candidate will possess a deep understanding of cGMP, global regulatory landscapes, and a proven ability to develop, implement, and maintain robust quality management systems. We are looking for a results-oriented leader with exceptional attention to detail, strong analytical skills, and the ability to effectively collaborate with cross-functional teams, including manufacturing, R&D;, and regulatory affairs. This role is pivotal in upholding the company's commitment to patient safety and product integrity.

Key Responsibilities

- Develop, implement, and manage the company's overall Quality Management System (QMS) in compliance with cGMP and other relevant regulations.
- Oversee all quality assurance activities, including batch record review, deviation investigations, CAPA management, change control, and OOS investigations.
- Conduct internal audits and support external audits by regulatory agencies and customers.
- Ensure that all manufacturing and laboratory processes are validated and compliant with regulatory standards.
- Manage the qualification and training of QA personnel, fostering a culture of quality and continuous improvement.
- Collaborate with R&D;, manufacturing, and regulatory affairs to ensure product quality from development through commercialization.
- Monitor key quality metrics, identify trends,



and implement corrective actions to mitigate risks and improve performance.
- Stay up-to-date with evolving regulatory requirements and industry best practices in pharmaceutical quality assurance.
- Serve as the primary point of contact for quality-related inquiries and ensure timely resolution of issues.

Requirements

- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 7 years of progressive experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of Current Good Manufacturing Practices (cGMP), ICH guidelines, and other relevant general regulatory requirements.
- Proven experience in developing and implementing Quality Management Systems.
- Strong understanding of validation processes (process, cleaning, analytical methods).
- Excellent leadership, team management, and interpersonal skills.
- Strong analytical and problem-solving abilities with meticulous attention to detail.
- Effective written and verbal communication skills, with the ability to present complex information clearly.
- Experience with electronic quality management systems (eQMS) is a plus.

Benefits

We offer a competitive compensation package, comprehensive health, dental, and vision insurance, life insurance, a robust retirement savings plan, and generous paid time off. This remote position provides excellent flexibility and work-life balance. You will have the opportunity to lead and shape the quality strategy of a respected pharmaceutical company, contributing to the delivery of safe and effective medicines worldwide. Our client is dedicated to professional growth, offering various training and development opportunities. Join a collaborative environment where quality is paramount and your contributions are highly valued.

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📌 Gerente de Aseguramiento de Calidad - Farmacéutico (Remoto) (Heroica Puebla de Zaragoza)
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📍 Heroica Puebla de Zaragoza