Madison, Wisconsin, United States
At the core of every thriving organization is a commitment to innovation, quality, and sustainability. Guided by the principles of strategic leadership and continuous improvement, I am driven by a passion to enhance operational efficiency and environmental stewardship. My philosophy centers around creating harmonious work environments where safety, quality, and growth meld seamlessly, fueling both individual and organizational success. With extensive experience in facilities management, budget oversight, and quality systems, I excel in identifying and implementing strategies that balance cost efficiency with superior performance. My expertise spans the complex realms of metrology, validations, and environmental health and safety, complemented by a robust understanding of systems project planning and manufacturing. I specialize in fostering cross-functional collaboration and developing high-performing teams that drive results. Throughout my career, I have led pivotal initiatives such as the implementation of the Safety, Quality, Delivery, Cost, and People (SQDCP) program, resulting in significant cost savings and improved operational readiness. My tenure as Site Director at Mallinckrodt Pharmaceuticals was marked by the achievement of a $1M cost-savings initiative and the successful reduction of environmental impact through substantial water and energy conservation efforts. Additionally, my leadership in facilities expansion projects has ensured our adherence to stringent quality and regulatory standards, a testament to my commitment to excellence. My mission is to partner with forward-thinking organizations to elevate operational efficiencies and environmental responsibilities. By aligning strategies with organizational goals, I aim to drive transformative change that not only meets but exceeds industry standards. If you are seeking a leader who blends technical proficiency with strategic insight, let's connect to explore how I can contribute to your organization's success and sustainability.
Stratatech - A Mallinckrodt Company Maintained site manufacturing and testing schedules, financial performance, supply chain, and audit readiness. Chaired site leadership team and represented site on weekly and monthly corporate operations and quality leadership meetings. Worked closely with strategic product lead, finance, and sales to develop manufacturing plan to meet projected sales for 2024. Created personnel hiring and development plan and identified key near-term and long-term projects necessary to meet sales forecasts and FDA commitments and requirements. Handled implementation of Safety, Quality, Delivery, Cost, and People (SQDCP) program at site. Provided clear communication between site and corporate leadership to support goals and initiatives. Implemented cost-savings initiative, leading to savings of $1M for CY 2023. Identified opportunities for water and energy savings as part of ESG program, saving 300K gallons of water and $40K of energy costs.
Managed site’s metrology and facility maintenance departments. Managed staff of eight with focus on equipment calibration and maintenance, metrology system management, and site facilities and utilities maintenance. Provided management and leadership of equipment- and department-related deviations, CAPAs, and change controls. Represented site in equipment and software validation and metrology systems during corporate / regulatory agency audits.
Managed site validation initiatives, focusing on equipment, facilities, and processes for new 20K-sq.-ft. facility expansion. Oversaw site EH&S management. Led development of systems to determine equipment, facilities, and processes requiring validation or commissioning. Authored documents and prioritized validation / commissioning activities. Managed team of five. Identified key quality attributes associated with development, production, testing, and storage of various work-in-process and finished products, including materials of construction / finishes, utilities (power, e-power, clean steam, process steam, purified water), plumbing, specialty gasses, environmental conditions, warehouse spaces, and Cold Rooms. Cold Room and warehouse spaces aseptic qualification (initial and recurring) of Clean Room qualification processes. Processed qualification once and recurring qualifications on six-month basis to demonstrate the facility and staff maintained their efficacy. Managed environmental compliance and permitting (Clean Air Act, TSCA, RCRA, wastewater), regulated waste disposal, and development of site health and safety programs and documents. Skills: Leadership Development · Culture Change · Key Performance Indicators · cGMP practices · Manufacturing Operations Management · Change Control · Employee Training · Training and Development (HR) · Computer System Validation · Interpersonal Skills · Lean Manufacturing · Operational Improvement · Recruiting · Verification and Validation (V&V) · Environment, Health, and Safety (EHS) · Continuous Improvement · Cross-functional Team Leadership · Budgeting · Written Communication · Manufacturing Operations · Collaborative Problem Solving · Operations · Engineering Management · Process Validation · HR Policies · Problem Solving · Operational Strategy
Responsibilities included consulting to a variety of FDA regulated companies in the areas of facilities commissioning and qualification, CAPA investigation and corrective action implementation, equipment IQ/OQ/PQ, and development of various cGMP documents. Facilities and equipment commissioning and qualification included identification and documentation of key quality attributes associated with development, production, testing, storage, and shipping of various work-in-process and finished products. Key quality attributes included materials of construction/finishes, utilities (power, e-power, clean steam, process steam, purified water), plumbing, specialty gasses, environmental conditions, Cold Rooms, etc. Documentation included written Facilities Requirements and Specifications, Construction Qualification Protocols, and Construction Qualification Reports. Other documents developed included various process work instructions, batch records for product purification and reagent production, updates to site validation master plans, equipment qualification protocols, and various reports.
Responsibilities include management of Hologic-Madison’s Engineering Services Department which encompassed metrology systems, facilities, and EH&S. Metrology system responsibilities consist of: calibration and maintenance of a variety of scientific and mechanical systems and equipment; equipment installation and qualification; maintenance of documentation, record keeping, and scheduling systems and databases; preparation of equipment use instructions, calibration procedures, qualification protocols, and various reports; and, participation on teams for product development and process improvement projects and business continuity planning. Environmental and Health and Safety responsibilities consist of: activities associated with compliance with Federal, State, and Local EH&S regulations for storm water, air emissions, hazardous waste, etc.; annual reporting for air permit compliance, hazardous waste generation, medical waste generation, Tier II, etc.; coordination and monitoring employee training with regard to Haz Com, PPE, DOT, etc.; interfacing with state and local regulatory personnel during regular audits and inspections; and, MSDS preparation. Facilities responsibilities include: budgeting for capital improvements and operating expenses; maintenance of building HVAC, refrigeration, plumbing, purified water, electrical, and other mechanical systems; building security system maintenance; and, evaluation and selection of contractors and service providers.
Managed projects involving Phase I Environmental Site Assessments, soil and ground water investigations and remedial actions, and geophysical investigations. Served a variety of clients representing commercial and industrial interests, attorneys, real estate developers, petroleum storage and distribution facilities, and government entities in industrial, commercial, residential, and rural/remote locations.