Quality Assurance Director (Chemistry)

About the Role:
The Quality Assurance Director oversees all quality systems, regulatory compliance, and audit readiness within a pharmaceutical manufacturing environment. This role ensures adherence to FDA regulations, cGMP standards, and internal quality policies while leading QA staff and managing quality operations from batch review to regulatory inspection response. The ideal candidate brings proven leadership experience in pharmaceutical QA, a strong understanding of FDA expectations, and a hands-on approach to maintaining compliance and product integrity.

Responsibilities:

• Direct and oversee all Quality Assurance functions, ensuring compliance with FDA, cGMP, and other applicable regulatory requirements.
• Lead QA teams in reviewing, approving, and maintaining documentation related to manufacturing, testing, and product release.
• Serve as the primary contact during FDA inspections, audits, and regulatory communications, ensuring timely and accurate responses.
• Develop, implement, and maintain robust quality systems, including CAPA, change control, deviation management, and document control.
• Oversee batch record review, product release, and quality investigations to ensure alignment with specifications and standards.
• Manage and mentor QA staff, promoting professional development and continuous improvement in quality processes.
• Collaborate cross-functionally with manufacturing, R&D, and regulatory teams to ensure consistent quality and compliance.
• Evaluate and enhance quality metrics and performance indicators to identify trends and drive process improvements.
• Ensure ongoing training and adherence to GMP, GLP, and safety practices across all departments.

Qualifications:

• Bachelors degree in Chemistry, Pharmaceutical Sciences, Quality Management, or a related field.
• 8 years of progressive experience in Quality Assurance within the pharmaceutical industry, including at least 3 years in a management or director-level position.
• In-depth knowledge of FDA regulations, cGMP, and pharmaceutical manufacturing processes.
• Proven experience managing and preparing for FDA inspections and regulatory audits.
• Strong understanding of quality systems, documentation control, and CAPA processes.
• Excellent leadership, communication, and organizational skills.
• Demonstrated ability to lead cross-functional teams and manage multiple priorities in a regulated environment.

Desired Qualifications:

• Masters degree in a scientific or technical discipline.
• Experience with sterile, liquid, or solid dosage form manufacturing.
• Familiarity with ICH, ISO, and other global quality standards.
• Expertise in quality risk management and process validation.
• Strong analytical and problem-solving abilities with a focus on continuous improvement.