Role Summary
Facilities Operations Manager responsible for governance and oversight of maintenance compliance and spare parts management within Facilities in Rockville, MD. The role ensures adherence to regulatory, quality, and company standards by managing deviations, CAPAs, change controls, and risk assessments, while establishing robust inventory control to maintain operational reliability and audit readiness.
Responsibilities
- Lead and manage facility maintenance compliance processes, including deviation management, CAPA development and tracking, and change control implementation. Ensure alignment with regulatory requirements, internal SOPs, and quality standards. Maintain inspection readiness and support audit activities.
- Conduct and/or facilitate maintenance-related risk assessments. Participate in safety and quality investigations, ensuring thorough root cause analysis and implementation of sustainable corrective and preventive actions.
- Support system and business owners in maintaining compliant maintenance programs, ensuring documentation, procedures, and workflows meet regulatory and corporate governance expectations.
- Oversee spare parts lifecycle management, including inventory control, forecasting, optimization, and obsolescence management. Ensure appropriate stock levels to mitigate operational risk while controlling carrying costs. Maintain accurate records within CMMS/ERP systems and support procurement alignment.
- Drive process improvements in compliance and inventory management systems to enhance reliability, reduce risk, and improve cost efficiency.
Qualifications
- Required: Bachelorβs degree in engineering, Facilities Management, Business Administration, or a related field
- Required: 3+ years of industry-related experience (CAPA management, deviation handling, change controls)
- Required: 3+ years of practical work experience in the pharmaceutical or other FDA-regulated field involving participation in technical writing
- Preferred: Solid organization, problem-solving, decision-making, judgment
- Preferred: Solid interpersonal skills to effectively communicate with all levels of the organization in various functional areas
- Preferred: Microsoft Word, Excel and Project experience