Director of Quality

Highlights of the Director of Quality Role This individual will set and enforce the laboratory's overall quality strategy, support the scale of operations to meet rising internal and external demand, ensure ongoing readiness for FDA, USP, and state board inspections, and have quality oversight for the laboratory's quality systems, including the performance, integrity, and continuous improvement of all analytical methods and instrumentation supporting our client. The role will report directly to the Vice President of Quality for the Company's North America region and have a dotted line to the Business Unit President. They will partner closely with Quality, Product Development, Procurement, Regulatory Affairs, and Operations personnel from our client and its other business units/subsidiaries, and will represent the business unit externally to clients, auditors, and regulators. High Visibility - The successful candidate will act as the Quality oversight authority within the laboratory and serve as a key client-facing quality representative. Fast-Paced Growth - Upon transitioning to a profit-driving entity, this business unit will have the opportunity to sell to our client's current clientele, who already rely on it for pre-tested pharmaceutical-grade raw materials - a built-in book of demand. Strategic Influence - The role owns the laboratory quality assurance strategy and regulatory readiness. Mission Alignment - Every test the lab runs ultimately protects a patient receiving a personalized, compounded, or specialty medication. The work matters. Key responsibilities include, but are not limited to: Implement and maintain a robust quality system that meets or exceeds cGMP regulations and other applicable quality standards, ensuring compliance across all lab procedures, documentation, and personnel. Ensure compliant and reliable testing services to meet internal customer needs and external market demand as the business unit scales. Establish and own robust systems for investigating and correcting deviations or failures in product quality - preventing contamination, mix-ups, or out-of-specification releases. Manage and audit the supply chain, verifying that suppliers' quality management systems are robust and that incoming raw materials meet specifications. Drive initiatives for continuous improvement, reducing errors, and detecting potential issues before they cause harm to patients or consumers. Ensure the laboratory is always prepared for internal self-evaluations and external regulatory inspections (FDA, state boards of pharmacy, USP, ISO), including meticulous documentation of all processes and full compliance with evolving regulatory guidance. Support the lab's strategic direction by understanding the latest industry trends, technologies (including automation and digital QC), and the regulatory landscape. Foster a culture where quality is a top priority for every employee in the laboratory and the broader organization. Oversee the validation of equipment and analytical methods, ensuring robust and accurate test methods. Partner with the Business Unit President on the commercial expansion of the analytical testing lab - including service-line scoping, client-facing technical engagements, pricing inputs, and capacity planning. Lead, mentor, and develop the Analytical Services team, including hiring, performance management, technical training, and succession planning. The Ideal Candidate The ideal candidate will possess an undergraduate degree in Pharmaceutical Sciences, Chemistry, Biology, Medical Laboratory Science, or a related field, with preferred experience in the Pharmaceutical industry. They possess a deep, up-to-date understanding of cGMP regulations governing laboratory controls, instrumentation, and data integrity. They have extensive experience working in a lab, are meticulous and highly conscientious, are skilled at identifying and mitigating risks, have a strong foundation in laboratory science and analytical methods, and can enforce and communicate clear procedures, as well as train personnel effectively. They will also possess excellent communication skills and a customer-centered mindset. #J-18808-Ljbffr