Job Description

QA/QC Director

Schedule: Monday–Friday, 8:30 AM – 5:00 PM (occasional extended hours or weekends)

About the Role

We are seeking an experienced QA/QC Director to lead quality operations and ensure compliance within a regulated pharmaceutical manufacturing environment. This position is responsible for the development and implementation of quality management systems, establishing quality standards, and monitoring regulatory requirements. The QA/QC Director will play a key leadership role, driving excellence, compliance, and continuous improvement across the organization.

Key Responsibilities

• Ensure the production facility operates at the highest operational and compliance standards.
• Lead, coach, and manage a team of chemists to ensure data integrity and achieve business objectives.
• Oversee departmental operations, ensuring only approved products and services are released.
• Develop and implement policies aligned with company objectives, ensuring compliance and accurate recordkeeping.
• Drive quality strategy in consultation with senior management and quality managers.
• Promote the implementation of robust quality systems across the organization.
• Oversee ANDA/NDA submissions and validation activities (processes, cleaning, analytical methods, facilities, and equipment).
• Provide leadership in problem-solving, CAPAs, and customer/supplier quality concerns.

Qualifications

• Bachelor’s degree in a scientific discipline.
• Minimum 10 years of experience in quality management within an FDA-regulated environment.
• Strong background in liquid manufacturing and packaging of Rx products .
• Proficiency with Empower 3, Word, and Excel .
• Hands-on experience with ANDA/NDA submissions and validation of processes, cleaning, analytical methods, facilities, and equipment.
• Deep knowledge of CFR, ICH regulatory guidelines, cGMP, and GDP .
• Strong technical knowledge of laboratory equipment, practices, and procedures.
• Excellent communication, problem-solving, and leadership skills.

Why Join Us?

This is an exciting opportunity to step into a key leadership role where you’ll shape quality strategy, mentor talented professionals, and make a lasting impact on product integrity and compliance. If you are a proactive leader with a passion for quality, we’d love to hear from you.

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