Director, Operations

Labcorp•Baltimore, MD

11d•Onsite

About The Position

Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science, data, technology and laboratory network, we advance diagnostics, accelerate innovation and help address some of the world’s most important health challenges. As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise, you’ll have the opportunity to do meaningful work, grow your career and make a real impact on people’s health around the world. Together, we’re improving health and improving lives. Labcorp Oncology is seeking a Director – Operations to join our team in Baltimore, MD. Work Schedule: Monday – Friday, 1st shift Job Summary: The Director of Operations is a senior leadership role responsible for leading Baltimore site operations within a highly regulated in vitro diagnostic (IVD) development and manufacturing environment, supporting strategically important projects, programs, and products. This position provides strategic and operational leadership across manufacturing, supply chain, engineering, business operations, facilities, quality collaboration, and environmental health & safety to ensure the delivery of high-quality products and services to internal and external customers. Reporting to the Vice President, Head of Science, Oncology and as a key member of the site leadership team, the Director of Operations is accountable for operational excellence across safety, quality, delivery, cost, compliance, and employee engagement. The successful candidate will have a demonstrated track record of leading high-performing, cross-functional teams and driving results in complex regulated environments including diagnostics, medical devices, biotechnology, pharmaceuticals, or other life sciences manufacturing organizations. This leader will partner closely with Quality, Regulatory Affairs, R&D, Commercial, and Corporate Functions to support product lifecycle activities from new product introduction through commercial manufacturing and sustaining operations. The Director of Operations will champion a culture of continuous improvement, accountability, compliance, and customer focus while ensuring the organization is positioned to meet current and future business demands.

Requirements

Bachelor's degree in Engineering, Operations Management, Supply Chain, Life Sciences, or related discipline.
10 or more years of progressive leadership experience in manufacturing, operations, supply chain, or engineering within a highly regulated industry such as IVD, medical devices, diagnostics, biotechnology, pharmaceutical, or life sciences.
5 or more years of experience in leading managers and multi-functional teams across manufacturing and operational disciplines.
5 or more years of experience supporting regulatory inspections, customer audits, and compliance activities.
5 or more years of experience with new product introduction (NPI), technology transfer, process validation, and commercial product manufacturing.
Deep understanding of FDA regulations, ISO 13485, cGMP, design controls, and quality management systems.
Demonstrated success managing complex manufacturing operations with direct accountability for safety, quality, delivery, inventory, and cost performance.
Proven ability to lead organizational transformation, operational scale-up, and continuous improvement initiatives.
Strong financial acumen, including budget development, capital planning, forecasting, and resource management.
Exceptional leadership, communication, stakeholder management, and change management skills.

Nice To Haves

Master’s degree or higher in Operations Management, Supply Chain, Life Sciences, or related discipline.
Lean Manufacturing and/or Six Sigma certification.
5 or more years of experience with 510(k), PMA, and IVD product development and commercialization.
5 or more years of experience operating within global manufacturing and supply chain environments.
5 or more years of experience managing facilities and EHS programs in a regulated laboratory or manufacturing setting.

Responsibilities

Provide leadership and direction to a multi-functional operations organization including manufacturing, supply chain, engineering, facilities, business operations, and environmental health & safety.
Establish and maintain a high-performance culture focused on accountability, employee development, operational excellence, and continuous improvement.
Lead manufacturing operations within a highly regulated environment, ensuring compliance with applicable FDA, ISO 13485, cGMP, and other global regulatory requirements.
Drive operational performance through defined metrics and KPIs related to safety, quality, customer service, inventory management, productivity, and cost.
Develop and execute strategic operational plans that support business growth, manufacturing scale-up, capacity planning, and long-term operational readiness.
Champion Lean Manufacturing, Six Sigma, and continuous improvement initiatives to enhance efficiency, reduce waste, improve quality, and optimize resource utilization.
Build and develop leadership capability across the organization through coaching, talent development, succession planning, and organizational effectiveness initiatives.
Lead operational readiness for regulatory inspections, customer audits, and certification activities while ensuring ongoing compliance with quality management systems.
Partner with Product Development and Engineering teams to ensure successful technology transfer, design transfer, new product introduction, and commercialization activities.
Own site-level operational performance, budget management, capital planning, and workforce strategy.