Looking for Audit Director, Quality & Compliance jobs? This senior leadership role sits at the critical intersection of quality assurance, regulatory compliance, and operational risk management within highly regulated industries like pharmaceuticals, biotechnology, medical devices, and finance. An Audit Director in this field is the strategic architect of an organization's audit program, ensuring it not only meets stringent global regulatory standards but also fosters a robust culture of quality and continuous improvement. Professionals in these jobs are responsible for developing and executing a comprehensive, risk-based audit strategy. This involves planning, leading, and overseeing a wide array of audits, including internal process audits, supplier/vendor audits, and for-cause investigations. Their core mission is to proactively identify gaps, systemic issues, and compliance risks before they escalate, thereby protecting the organization's integrity, product quality, and patient or customer safety. A typical day involves evaluating processes against regulations like FDA CFR, EMA, ICH guidelines, or financial compliance standards, and ensuring audit observations are effectively addressed through robust Corrective and Preventive Action (CAPA) plans. Common responsibilities for an Audit Director include building, mentoring, and leading a team of audit professionals, providing them with technical guidance and fostering their development. They serve as a key liaison between the audit function and senior operational leadership, translating audit findings into strategic business insights. A significant part of the role is also dedicated to enterprise-wide inspection readiness, acting as a subject matter expert during regulatory agency inspections and helping functional teams prepare for and respond to regulatory inquiries. Furthermore, they are instrumental in maintaining and enhancing the Quality Management System (QMS), updating audit-related SOPs, and feeding risk assessments into the broader organizational risk framework. Typical skills and requirements for these high-level jobs include a bachelor’s or advanced degree in a relevant scientific, quality, or business discipline, coupled with 10+ years of progressive audit and compliance experience within a regulated sector. Candidates must possess an expert understanding of applicable regulations (GxP, SOX, etc.), exceptional analytical and problem-solving skills, and outstanding communication and influence abilities to partner with cross-functional stakeholders. Leadership experience, including people management and strategic program development, is essential. Professional certifications such as Certified Quality Auditor (CQA), RQAP, or similar are highly valued. Success in this profession demands a unique blend of meticulous attention to detail, strategic vision, and the ability to navigate complex regulatory landscapes to safeguard organizational excellence. Explore Audit Director, Quality & Compliance jobs to find a career where you become a guardian of quality and a driver of strategic compliance.
