Job Summary:

We are seeking an experienced and dedicated Director of Quality Assurance to lead our QA & QC teams in a pharmaceutical manufacturing environment. The ideal candidate will possess extensive knowledge and expertise in current Good Manufacturing Practices (cGMP), United States Pharmacopeia (USP) Chapter 797, and be familiar with section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This position is crucial to ensuring our products meet the highest quality standards and regulatory requirements.

Qualifications:

• Bachelor's degree in Chemistry, Biology, or a related field; advanced degree preferred.
• Minimum of 10 years of experience in quality assurance within the pharmaceutical
• In-depth knowledge of cGMP regulations and USP Chapter 797 requirements.
• Proven experience in leading and managing Quality teams in a pharmaceutical manufacturing environment.
• Strong understanding of regulatory requirements and quality standards applicable to the pharmaceutical industry.
• Excellent communication, leadership, and organizational skills.
• Ability to work effectively in a fast-paced, dynamic environment.
• Strong analytical and problem-solving abilities.

Preferred Qualifications:

• Certification in quality management (e.g., ASQ Certified Quality Auditor, Certified Quality Manager).
• Experience with quality systems software and electronic documentation management systems.
• Familiarity with sterile manufacturing processes and aseptic techniques.