Associate Director of Quality Assurance

Our client is hiring an Associate Director or Director of QA. This role will provide leadership, management and responsibility for Quality Assurance Investigations and Operational Auditing functions. Ensures all quality-related corrective measures related to investigations, deviations, change controls, CAPAs, and complaints are conducted, documented, and closed in compliance with FDA, cGMP, and company procedures. Provides strong investigation and report writing skills as a lead author of high criticality Quality Assurance reports and investigations. Oversees quality systems, documentation management, and internal audit coordination to ensure data integrity and continuous improvement within Quality Operations.

REQUIREMENTS:

SKILLS/KNOWLEDGE AND/OR ABILITIES

• Comprehensive understanding of cGMP regulations and FDA expectations for documentation and investigations
• Demonstrated expertise in deviation investigations, CAPA management, and root cause analysis
• Strong investigation and report writing skills with working knowledge of quality systems, change control, and document control processes
• Experience with audit preparation, management, and follow-up for both internal and regulatory inspections
• Excellent organizational skills and attention to detail in document review and recordkeeping
• Strong analytical and problem-solving abilities with a data-driven approach
• Ability to lead cross-functional teams in investigation and CAPA resolution activities
• Skilled in communication with internal teams, regulatory agencies, and external partners
• Proficiency in use of Quality Management Systems (QMS) and document control software
• Ability xuwmhxw to train, coach, and develop personnel in investigation techniques and quality system processes

EDUCATION

• Required: Baccalaureate degree in Chemistry, Pharmacy, Biology, or related scientific discipline
• Preferred: Advanced certification in Quality Management, Quality Auditing, or related field

EXPERIENCE

• 10 years experience directly related to pharmaceutical manufacturing and quality assurance operations ideally with at least 5 years of management experience