Senior Manager of Quality Assurance

Overview Our client is hiring a Senior Manager of QA and Operational Audits. 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 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 Required: 5-8 years of experience in pharmaceutical quality assurance, including investigation and documentation management Preferred: 2-5 years of leadership or supervisory experience in a GMP-regulated pharmaceutical or biopharmaceutical environment. Solid-dose manufacturing experience preferred #J-18808-Ljbffr