Director of Operations

Purpose

The Director of Operations provides strategic and operational leadership to ensure efficiency, complaint, and seamless distribution across the organization. This position oversees cross-functional operations teams and collaborates closely with Quality, Regulatory, Supply Chain, Customers, Distribution Channels, and International markets as needed.  In this role, the Director of Operations ensures alignment with organizational goals, KPI’s, regulatory standards, and domestic/international customer expectations.

Responsibilities

• Leads and oversee all operational functions including production, engineering, facilities, maintenance, inventory/warehouse management, customer service/order management, contract manufacturing, project management, cold chain distribution, safety, supply chain, quality/regulatory alignment, laboratory testing, warehouse distribution, continuous improvements, drives/tracks KPI’s and ensures tight cost containment and efficiency standards are consistently achieved.
• Supports business after-hours or on-call support remotely or on-site as needed, for operations support, environmental monitoring alarms, personnel issues, and/or emergency events.

• Identify/track/present and own Key Performance Indicators (KPIs) to assess risk, track metrics, and provide routine performance reporting to executive management.  Post KPI’s electronically or in hard copy for site personnel and executive management.
• Plan and direct lean/continuous improvement process improvement projects to optimize workflows, reduce operational costs, and deliver profit optimization.
• Closely monitor/control financial spending related to site expenditures, travel, and CAPEX.

• Collaborate with cross-functional/cross-division leaders to set continuous improvement (CI) initiatives striving for world-class operational excellence.
• Strengthen team capabilities by identifying skill gaps, implementing targeted training programs, and supporting cross-training and succession planning.
• Support executive management with long-term operating goals, revenue generation opportunities, and implementation of new technology.

• Supports operational integration related to acquisitions, including training, personnel, ERP, systems, QMS, GMP/GDP/GLP, and assets.

• Communicate organizational updates and operational changes to ensure alignment with company mission, vision, strategy and values at all levels.
• Ensure adherence/compliance to cGMP/GMP, GDP, GLP, FDA CFR’s, quality, and customer requirements across all operational functions.
• Support internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, accreditation/certification requirements, and internal policies and procedures.
• Participate in operational, CAPEX and budget planning activities, including feasibility assessments, cost-benefit analysis, ROI justification, design considerations, and regulatory planning.
• Build and maintain long-lasting, strong relationships with customers, vendors, and suppliers.
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.
• Provide constructive feedback and guidance to develop & mentor team members and leadership to reach their full potential.
• Develop and monitor SMART performance goals that align with corporate, site, and individual goals/objectives for all salaried employees.
• Develop standard goals & objectives for operations and operations-related team members. (i.e., production, testing, lab, shipping/receiving, material handlers, etc.)
• Collaborate with quality/regulatory counterparts to ensure team alignment to corporate, site, and Q&R compliance goals are being met.
• Develop structured quarterly/end-of-year performance reviews directly tied to personal, departmental, site, and corporate goals. Hold personnel accountable for goal attainment through corresponding merit increases, bonuses, and possible promotion/disciplinary proposals. 
• Monitor/measure employee/team morale through retention and attrition.
• Possible travel up to 15% to attend offsite meetings, conferences, and support business initiatives.
• Ensure acceptable attendance, punctuality, and timely completion of tasks.
• Maintain flexibility to work outside of normal business hours during weekdays or weekends, as necessary, to meet operational needs and ensure business continuity. Influence other team members to do the same as business requirements dictate.
• Lead cross-functional execution across Operations, Quality, Regulatory, Supply Chain, and Engineering to ensure projects are delivered on time, on budget, within scope, and in full compliance with FDA, ISO, and applicable regulatory requirements.
• Ensure onsite, CMO partners and vendors are meeting production forecast/demand requirements.
• Track MOH inventory goals are inline with sale forecast and actual demand based on historical usage and cyclical trends.
• Perform other duties as assigned.

Skills

• Strong leadership and mentoring abilities.
• Deep understanding of inventory management and operational processes.
• Adaptability to manage changing priorities and operational demands.
• Ability to employ strong budget, process, profit optimization, and project management skills to drive operational efficiencies and outcomes.
• Strong analytical and problem-solving skills to identify inefficiencies and implement sustainable solutions.
• Excellent attention to detail and organization.
• Excellent written and verbal communication.
• Highest level of ethics and integrity.
• Ability to multitask and work in a fast-paced environment.
• Strong technical writing.
• Effective project management.
• Proficiency in Microsoft Office.

Qualifications/Requirements

• Bachelor’s degree in Business, Engineering, Supply Chain, or related field required.
• At least 8-10 years of experience in operational, supply chain/logistics, finance, or relevant leadership roles, or related field with progressive management experience required.
• Clearance of a favorable background investigation is required.