Director, Operations (IVD Manufacturing)

Location: Baltimore, Maryland, United States; the posting also lists Charlotte, Durham, Chantilly, Richmond, and Burlington, United States. Monday–Friday, first shift.

Salary: $150,000–$175,000 per year, plus eligibility for an annual bonus.

Company

hirify.global provides laboratory services, diagnostics, data, and technology solutions for healthcare providers, patients, researchers, pharmaceutical companies, and health systems.

What you will do

• Lead a multifunctional operations organization spanning manufacturing, supply chain, engineering, facilities, business operations, and environmental health and safety.
• Direct regulated IVD manufacturing operations and maintain performance across safety, quality, delivery, inventory, productivity, cost, and compliance.
• Develop operational plans for business growth, manufacturing scale-up, capacity planning, and long-term readiness.
• Lead Lean Manufacturing, Six Sigma, continuous improvement, technology transfer, design transfer, new product introduction, and commercialization activities.
• Prepare operations for FDA and customer inspections, audits, certifications, and quality-system requirements.
• Manage site performance, budgets, capital planning, workforce strategy, leadership development, and succession planning.

Requirements

• Bachelor’s degree in Engineering, Operations Management, Supply Chain, Life Sciences, or a related discipline.
• 10+ years of progressive leadership experience in manufacturing, operations, supply chain, or engineering within a highly regulated industry.
• 5+ years leading managers and multifunctional teams across manufacturing and operational disciplines.
• 5+ years supporting regulatory inspections, customer audits, compliance activities, new product introduction, technology transfer, process validation, and commercial manufacturing.
• Strong knowledge of FDA regulations, ISO 13485, cGMP, design controls, quality management systems, financial planning, and change management.

Nice to have

• Master’s degree or higher in Operations Management, Supply Chain, Life Sciences, or a related discipline.
• Lean Manufacturing or Six Sigma certification.
• Experience with 510(k), PMA, IVD product development and commercialization, global manufacturing and supply chains, facilities, and EHS programs.

Culture & Benefits

• Leadership role within a regulated life sciences manufacturing environment focused on accountability, compliance, continuous improvement, and customer focus.
• Medical, dental, vision, life, short- and long-term disability coverage, and a 401(k) plan.
• Paid time off or flexible time off, tuition reimbursement, and employee stock purchase plan.
• Employee eligibility for comprehensive benefits begins at 20 or more regularly scheduled hours per week.