Pursue a pivotal leadership role at the intersection of science, compliance, and patient safety by exploring Director, GxP Quality Assurance jobs. This senior executive position is the cornerstone of quality and regulatory compliance within the life sciences industry, encompassing pharmaceuticals, biotechnology, medical devices, and cell and gene therapy. Professionals in this role are responsible for the strategic design, implementation, and oversight of the company's entire Good Practice (GxP) Quality Management System (QMS), ensuring all activities from non-clinical research (GLP) through manufacturing (GMP) to clinical trials (GCP) meet rigorous global regulatory standards. A Director of GxP Quality Assurance typically leads a comprehensive portfolio of responsibilities. Central to the role is building, scaling, and maintaining a robust, risk-based QMS that is both compliant and efficient. This involves authoring and governing high-level quality policies and standard operating procedures (SOPs), and often acting as the business owner for electronic quality management systems (eQMS). They provide integrated QA oversight across all drug development functions, ensuring a seamless quality culture from lab to clinic. A critical duty is managing a risk-based audit program, which includes conducting and overseeing audits of critical third-party vendors like Contract Research Organizations (CROs), clinical trial sites, and contract manufacturing partners (CMOs). Furthermore, they are accountable for key quality processes such as managing deviations, conducting root cause analysis, implementing corrective and preventive actions (CAPA), and overseeing change control. Directors in this field champion inspection readiness, leading preparations for and hosting regulatory agency inspections, and are key contributors to regulatory submission strategies. Candidates seeking Director, GxP Quality Assurance jobs must possess a strong blend of technical expertise, leadership acumen, and strategic vision. Typical requirements include an advanced degree in a life science or related field and a minimum of 10+ years of progressive GxP QA experience within the regulated industry. In-depth, current knowledge of global GCP regulations is paramount, complemented by strong working knowledge of GMP and/or GLP. Proven experience in building or significantly maturing a QMS in a growth-phase environment is highly valued. Essential skills include expertise in vendor audit management, a solid understanding of data integrity principles and computerized system validation (CSV), and the ability to analyze quality metrics to drive continuous improvement. Successful directors are influential leaders, excellent communicators, and adept at fostering a quality mindset throughout the organization, making this role critical for any company navigating the complex path of product development and regulatory approval.
