Director of Facilities - Medical Device/Diagnostics

Werfen•Norcross, GA

4d•Hybrid

About The Position

The Facilities Leader plays a critical role in ensuring the Transfusion sites remain safe, compliant, reliable and fully operational, enabling employees and core business activities to function effectively and without disruption. This role is accountable for leading a team of Facilities and Maintenance professionals dedicated to maintaining facilities, grounds, equipment, and environmental health and safety for diagnostic manufacturing, distribution, and business functions as well as supporting the ongoing success and strategy for the Transfusion business. This leader is responsible for all aspects of facility operations, infrastructure, compliance, and expansion across 3 sites located in Georgia, New Jersey and Nova Scotia, Canada. The role is highly cross-functional and requires both strategic planning and hands on execution.

Requirements

Bachelors degree in engineering, construction management, architecture, facilities management or a related field required, with Certified Facility Manager (CFM) designation highly preferred.
Minimum of 10 years leading Facilities teams in a regulated and diagnostics environment required.
Strong working knowledge of all building systems, both mechanical and controls, including HVAC, electrical, DI water systems, refrigeration, compressed air, emergency, and plumbing systems.
Strong working knowledge of filling, labeling and packaging systems.
Experience in construction and project management as well as external contracted services.
Experience in FDA regulated industries and knowledge of GMPs.
Experience building high performing teams and driving continuous improvement.
Experience in Clean Room ISO 14644 and ISO 13485 Standards.
Experience in equipment automation and maintenance.
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Strong written and verbal communication skills, with the ability to build effective relationships across functions, levels, and external partners.
Demonstrated ability to lead and develop teams, creating a collaborative and accountable team culture.
Strong critical thinking, problem-solving, and situational adpatability in complex or ambiguous environments.
Ability to make sound decisions that integrate technical, financial, operational, and business considerations.
Excellent understanding of GDP, GMP, Good Laboratory Practices (GLP), FDA, and ISO.
Ability to operate with high level of autonomy and multi task, managing both strategic and daily tactical activities.
Proficient computer skills including Microsoft Office, project management tools, and Quality Systems.
Results-oriented leadership approach with the ability to align execution, ensure accountability, and deliver measurable outcomes.
Knowledge of life safety systems.

Nice To Haves

Certified Facility Manager (CFM) designation highly preferred.

Responsibilities

Own end-to-end operations of 3 sites with combined office, medical diagnostics manufacturing, and distribution facility, ensuring safety, reliability, and operational excellence across all buiding systems and campuses.
Build and manage a high-performing, lean facilities, maintenance, calibration and safey team with clear accountablity and performance standards for both internal resources and external contracted services.
Develop and execute long and short term strategic plans to maintain and improve facility systems, buildings and infrastructure in alignment with business strategic plans.
Oversee maintenance of critical infrastructure and manufacturing equipment (HVAC, environmental systems, electrical, plumbing, fire and life safety, filling, labeling and packaging) with strong preventative maintenance, calibration programs and rapid responses to maintain required operating conditions for production, including uptime, redundancy planning, capacity forecasting, cost control, and efficiency.
Manage and direct physical security and access control systems, ensuring a safe and controlled environment across all campuses.
Ensure clean, well-maintained, fully functional, and efficient workspaces across campuses.
Partner with internal and external project management, contractors and architects on construction, renovation, and site expansion. Lead facility build-outs from concept through execution, including budgeting, permitting, and timelines, ensuring all projects meet operational, safety, and compliance standards.
Manage third-party vendors, establishing contracts and SLAs to ensure high quality and cost effective service, including vendor selection, requirements, quotation, contract negotiation, and ongoing performance management.
Lead and own Site Master Plan and Business Continuity Plan for the sites, identifying improvements, risks and mitigations, and executing on improvements.
Lead Environmental Health & Safety program including safety education and training, policies and procedures, accident prevention, audits and inspections, environmental and hazardous material management, safety culture, promotion of safe working habits and conditions to ensure safety of employese and site as well as compliance to regulatory agencies and company policies. Identify areas of improvement and work with cross functional leadership to implement corrective actions and improvements.
Implement and maintain emergency preparedness plans and incident response protocols, and serve as the around-the-clock emergency point of contact for facility-related issues.
Ensure full compliance with OSHA, building codes, fire regulations, and environmental standards, and own audit and inspection readiness across all regulatory bodies and internal quality management system for facilities related systems.
Create and implement policies and procedures to maintain compliance, performance, and safety of facilities and equipment.
Provide technical, logistical, and planning expertise to resolve all facility related issues.
Develop and manage facilities budget for both operational expenses and capital investments.
Performs other duties and responsibilities as assigned.