Director, QC

About the role

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Essential Duties and Responsibilities: This position provides strategic and operational leadership for Quality Control Department within a fast-paced, multi-client CDMO environment. The role oversees QC Chemistry, Method Transfers, Stability, Raw Materials, and Logistics operations supporting GMP manufacturing, release testing, investigations, and regulatory compliance. This people leader is responsible for driving laboratory excellence through robust quality systems, laboratory infrastructure, and electronic platforms (LIMS/CDS/SDMS), while delivering practical, data-driven solutions that strengthen compliance, efficiency, and business performance. Success in this role requires a highly collaborative and influential leader who can build highperforming teams, develop future leaders, and foster a culture of accountability, innovation, and continuous improvement while ensuring the highest standards of product quality and operational execution. Core Responsibilities Lead and provide strategic direction for Quality Control Department supporting GMP manufacturing activities, including method transfer, in-process testing, method verification, release testing, stability programs, and reference standard qualification. Drive innovation and continuous improvement at the strategic site level while ensuring disciplined tactical execution across laboratory operations. Oversee all laboratory infrastructure and support systems required for GMP testing and release activities, including sample management, statistical support, and electronic laboratory systems. Provide leadership for laboratory electronic systems management and associated scientific software used to generate and maintain electronic records and batch release data. Provide scientific leadership and technical problem-solving support for complex laboratory and manufacturing challenges. Lead generation and review of batch release data, certificate of analysis issuance, final product disposition, and stability trending/shelf-life analysis. Analyze operational and quality data to identify trends, deliver actionable insights, and implement practical solutions that improve compliance, efficiency, and performance. Partner cross-functionally to develop sustainable quality systems, strengthen operational controls, and ensure the highest level of product quality and compliance. Establish and implement robust systems for tracking, escalating, and driving closure of quality records and laboratory events, including Deviations, CAPAs, OOS investigations, and audit observations. Support development of meaningful KPIs and metrics that provide visibility to laboratory performance, quality trends, and continuous improvement opportunities. Manage departmental budget, headcount planning, capital projects, and resource allocation to support current and future business needs. Serve as a client-facing SME for Analytical Technologies and QC matters, supporting client interactions, process transfers, investigations, testing strategies, and regulatory discussions. Maintain consistent on-site leadership presence and engagement to support operations, teams, and business priorities. Leadership Responsibilities Lead with impact, influence, and accountability while fostering a culture of collaboration, engagement, and continuous improvement. Build and develop a high-performing laboratory organization by coaching leaders, mentoring team members, and strengthening organizational capability and succession planning. Build strong cross-functional partnerships to align quality and laboratory operations with broader site and company objectives. Establish high-performance expectations, clear accountability, and a results-driven environment focused on operational excellence and compliance. Drive employee engagement and development through coaching, delegation, goal setting, performance management, and continuous feedback. Maintain transparent and effective communication across teams and organizational levels. Champion practical, data-driven decision-making and continuous improvement initiatives that reduce variability, increase efficiency, and strengthen compliance. Provide leadership to ensure adherence to EHS policies, GMP requirements, and PCI Pharma Services quality standards. Embody PCI Pharma Services' cultural values through daily leadership behaviors, professionalism, collaboration, and commitment to excellence. Develop and execute short- and long-term organizational strategies that strengthen technical capability, operational readiness, and business growth. Represent the organization with professionalism and credibility during client interactions, audits, insp

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Company Intel

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