Operations & Manufacturing Manager in Hallandale

Job DescriptionJob DescriptionOperations & Manufacturing Manager

Lavior Pharma is seeking an experienced Operations & Manufacturing Manager to oversee manufacturing operations, supply chain management, and regulatory coordination.This role will manage contract manufacturers (CDMOs), suppliers, and production planning while ensuring manufacturing operations comply with ISO 13485 quality standards and FDA regulatory requirements.The Operations & Manufacturing Manager will play a key role in scaling Lavior’s manufacturing capabilities while maintaining regulatory compliance and operational efficiency.

This position reports directly to the CEO.
Key Responsibilities:Manufacturing & CDMO ManagementServe as the primary operational liaison with contract manufacturers (CDMOs).Oversee production planning, batch scheduling, and manufacturing timelines.Monitor manufacturing performance including lead time, yield, and cost efficiency.Ensure manufacturing documentation, batch records, and traceability systems are maintained and audit-ready.Support scale-up initiatives and process improvements.Supplier & Contract Manufacturer SourcingIdentify, evaluate, and onboard new contract manufacturers, CDMOs, and production partners.Source and qualify new suppliers and vendors for manufacturing components and raw materials.Manage sourcing for production materials including:

• tubes
• packaging
• boxes
• printed materials
• components and labeling

Conduct supplier qualification and coordinate quality agreements.Perform supplier performance reviews and maintain approved supplier lists.Supply Chain & Production PlanningDevelop production forecasts and manufacturing plans aligned with company growth.Coordinate procurement and inventory planning to ensure supply availability.Manage lead times, logistics, and supplier performance.Implement systems to improve manufacturing efficiency and supply chain reliability.Cost Optimization & Pricing SupportAnalyze manufacturing costs and identify opportunities for cost optimization.Support leadership in product pricing strategy and margin improvement.Evaluate alternative suppliers and manufacturing processes to reduce costs while maintaining quality standards.Quality & ISO 13485 ComplianceSupport and maintain manufacturing operations aligned with ISO 13485 Quality Management System requirements.Ensure CDMOs and suppliers comply with quality standards and documentation requirements.Assist in implementing SOPs, CAPA processes, and quality documentation.Support preparation for quality audits and regulatory inspections.Regulatory & FDA CoordinationCoordinate testing with FDA-compliant laboratories, including:

• biocompatibility testing
• assay validation
• stability testing
• medical device product testing
• Support regulatory activities including:
• FDA 510(k) submissions
• OTC regulatory requirements
• 21 CFR Part 211 (pharmaceutical GMP)
• 21 CFR Part 820 (medical device QSR)

Logistics & OperationsCoordinate product logistics and supply chain operations.Ensure inventory availability to support U.S. and international growth.Implement operational processes that support scalable manufacturing.
Required Experience5–10+ years experience in manufacturing operations, supply chain, or production management.Experience working with contract manufacturers (CDMOs).Experience sourcing and qualifying new suppliers and manufacturers.Experience in medical devices, pharmaceuticals, OTC products, or regulated skincare manufacturing.Technical KnowledgeProduction planning and manufacturing operationsSupply chain management and procurementISO 13485 quality systemsFDA regulatory frameworks including:

• 510(k)
• OTC compliance
• 21 CFR 211 and 820

EducationBachelor’s degree in one of the following:Biomedical EngineeringChemical EngineeringIndustrial EngineeringPharmaceutical SciencesSupply Chain / Operations Management

Advanced degree or ISO 13485 / regulatory certification is a strong advantage.
Key SkillsManufacturing process optimizationVendor negotiation and supplier qualificationRegulatory and quality complianceProduction forecasting and planningCost optimization and margin managementCross-functional leadership

Why Join LaviorWork with innovative botanical-based medical technologiesHelp scale a company entering global marketsBuild and optimize manufacturing infrastructureWork directly with executive leadership to drive operational growth