Job Title: Quality Director

Job Description

The Director of Quality is a senior leader responsible for overseeing all quality and regulatory functions within a cGMP-compliant manufacturing environment. This role ensures that products meet internal and external standards while fostering a culture of continuous improvement and compliance.

Responsibilities

• Lead Quality Assurance, Quality Control, Regulatory Affairs, and Training teams.
• Develop and execute quality and compliance strategies aligned with business goals.
• Oversee Quality Management Systems (QMS) and ensure compliance with FDA, cGMP, and industry standards.
• Manage audits, inspections, and regulatory submissions.
• Supervise laboratory operations, including testing, validation, and equipment maintenance.
• Promote a strong quality culture through training and cross-functional collaboration.

Essential Skills

• Extensive experience in quality assurance and regulatory affairs within a cGMP-compliant environment.
• Proven leadership in managing teams and developing quality strategies.
• Strong understanding of Quality Management Systems (QMS) and compliance with FDA and industry standards.

Work Environment

The work environment is a cGMP-compliant manufacturing setting. The role involves collaborating with cross-functional teams and promoting a culture of quality and continuous improvement.