Purpose
The Senior Operations Manager provides leadership and oversight of day-to-day operational activities to ensure efficient, compliant, and seamless operations across the organization. This role manages key operational functions and works closely with Quality, Regulatory, Supply Chain, Customer Service, Distribution, and external partners to support organizational objectives. The Senior Operations Manager is responsible for driving operational performance, supporting continuous improvement initiatives, maintaining regulatory compliance, and ensuring customer expectations are met in domestic and international markets.
Responsibilities
- Manage and oversee operational functions including production, facilities, maintenance, inventory and warehouse management, customer service and order management, contract manufacturing support, project coordination, cold chain distribution, safety, laboratory operations, and warehouse distribution.
- Support after-hours and on-call operational needs as required, including environmental monitoring alarms, personnel issues, and emergency response situations.
- Monitor, analyze, and report Key Performance Indicators (KPIs) to assess operational performance, identify risks, and support management decision-making.
- Lead continuous improvement initiatives and process improvement projects to enhance productivity, quality, efficiency, and cost control.
- Monitor and control departmental spending, operating expenses, travel budgets, and capital expenditures in partnership with leadership.
- Collaborate with cross-functional teams to implement operational excellence and continuous improvement programs.
- Identify skill gaps and support employee development through training, cross-training, and succession planning initiatives.
- Support leadership in achieving operational goals, revenue growth initiatives, and implementation of new processes and technologies.
- Assist with operational integration activities related to acquisitions, including systems, processes, training, quality systems, and personnel alignment.
- Communicate operational updates and process changes to employees to ensure organizational alignment and effective execution.
- Ensure compliance with cGMP, GDP, GLP, FDA regulations, ISO requirements, and customer specifications across operational functions.
- Participate in internal, customer, and regulatory audits and support corrective and preventive actions as needed.
- Contribute to annual budget planning, operational forecasting, capital projects, and resource planning activities.
- Develop and maintain strong working relationships with customers, suppliers, contract manufacturers, and service providers.
- Maintain knowledge of applicable regulations, standards, and internal procedures, including FDA 21 CFR requirements, AATB standards, ISO standards, and cGMP guidelines.
- Coach, mentor, and provide performance feedback to employees and front-line supervisors.
- Establish and monitor SMART goals aligned with departmental and organizational objectives.
- Support performance management processes, including annual reviews, development plans, and employee accountability measures.
- Monitor employee engagement, retention, and turnover metrics and partner with leadership to address workforce concerns.
- Travel up to 15% as needed to support business initiatives, customer meetings, audits, or operational projects.
- Ensure attendance, productivity, and timely completion of assigned work responsibilities across the team.
- Maintain flexibility to support operational requirements outside normal business hours as business needs dictate.
- Partner with Operations, Quality, Regulatory, Supply Chain, and Engineering teams to execute projects on time, within budget, and in compliance with applicable regulations.
- Monitor production schedules and vendor performance to ensure forecasted demand and customer requirements are met.
- Track inventory levels and material availability to support operational needs while achieving inventory management objectives.
- Perform other duties as assigned.
Skills
- Strong leadership, coaching, and team development abilities.
- Knowledge of manufacturing, supply chain, inventory management, and operational processes.
- Strong project management and organizational skills.
- Ability to analyze data, identify trends, and implement operational improvements.
- Experience managing budgets, expenses, and operational performance metrics.
- Strong problem-solving and decision-making capabilities.
- Excellent verbal and written communication skills.
- High level of professionalism, ethics, and integrity.
- Ability to manage multiple priorities in a fast-paced environment.
- Strong technical documentation and reporting skills.
- Proficiency with Microsoft Office and ERP/business management systems.
Qualifications/Requirements
- Bachelor's degree in Business, Engineering, Supply Chain, Operations Management, or a related field required.
- Minimum of 5-8 years of experience in operations, manufacturing, supply chain, logistics, or related business functions, including progressive leadership responsibilities.
- Prior experience managing teams and operational performance metrics required.
- Experience within a regulated environment (FDA, ISO, cGMP, GDP, GLP, or similar) preferred.
- Successful completion of a background investigation, as applicable.
