Director, Operations

PGD Personal Genome Diagnostics Inc.; Baltimore (MD); On-site; USD 150,000 - 175,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) Plan

PTO / FTO

Tuition Reimbursement

Employee Stock Purchase Plan

Job summary

Labcorp is seeking a Director of Operations for the Baltimore site, leading a highly regulated IVD development and manufacturing environment. This senior leader will oversee manufacturing, supply chain, engineering, facilities, quality, and EHS to ensure safe, compliant, high-quality products while driving efficiency and cost leadership.

The role partners with Quality, Regulatory, R&D, and Commercial functions to support lifecycle activities from NPI through commercialization, with

Qualifications

• 10+ years leadership experience in regulated manufacturing/ops.
• 5+ years leading managers and multi-functional teams.
• 5+ years supporting regulatory inspections and audits.
• 5+ years with NPI, technology transfer, process validation.

Responsibilities

• Lead multi-functional operations including manufacturing, supply chain, engineering, facilities, and EHS.
• Establish high-performance culture focused on accountability and continuous improvement.
• Ensure compliance with FDA, ISO 13485, cGMP and global requirements.
• Drive KPIs for safety, quality, delivery, inventory, productivity, and cost.
• Oversee technology transfer and new product introduction with product development teams.

Skills

Leadership

Regulated industry

Cross-functional leadership

Operations management

Quality & compliance

Budget management

Strategic planning

Education

Bachelor's degree in Engineering, Operations Management, Life Sciences, or related

Master’s degree in Operations Management, Life Sciences, or related

Job description

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.

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.

Job 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.

Minimum Qualifications

• 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.

Preferred Qualifications

• 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.

Additional Job Standards

• 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.

Pay Range

Pay Range: $150k - 175k. All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. The position is also eligible for an annual bonus under the Labcorp Bonus Plan. Bonuses are payable based on corporate and/or business segment performance and are subject to individual performance modifiers.

Benefits

• Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan.
• Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan.

Equal Opportunity Employer

Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.

About Labcorp

We believe in the power of science to change lives. Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. Here, you can join our nearly 70,000 employees, serving clients in more than 100 countries, as we work together to transform approaches to patient care.