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Time to market and regulatory compliance are critical success factors in the world of biotechnology. These two factors were significant hurdles for a global biotech company that faced an ambitious 18-month deadline to establish a cGMP-compliant plant. With limited resources, a lean executive team, and the crucial need for robust system adoption, the company required strategic intervention. This is where an Interim CIO from Fortium Partners stepped in to transform challenges into triumphs and set a new benchmark for operational excellence in the biotech sector.
The Biotech Landscape: Navigating Aggressive Timeliness and Resource Constraints
Fortium’s client, a global biotech company founded in 2006, has nearly 100 employees and received private equity funding in 2019 to fuel an aggressive expansion plan. The cornerstone of this plan was to establish a cGMP-compliant manufacturing facility within 18 months. This endeavor was not just ambitious; it was a race against the clock to unify the necessary equipment, processes, technology, and human resources to support future growth and meet stringent regulatory requirements.
Compounding this challenge were significant resource constraints. At the project’s inception, the site’s executive team was predominantly composed of consultants, with only three permanent employees and minimal support staff. This skeletal structure hindered swift decision-making and efficient execution, both of which were critical to achieve the tight deadline. Additionally, even after the implementation and validation of critical systems at their newest manufacturing site, the team faced another hurdle: ensuring effective system adoption. New hires lacked established processes to operate the plant efficiently and struggled with a full understanding of their data, creating a potential bottleneck.
The Fortium Solution: Strategic Vision and Flawless Execution
Recognizing the urgent need for seasoned leadership and a pragmatic approach, the biotech company engaged an Interim CIO from Fortium Partners. This leader brought a wealth of expertise in pharmaceutical regulatory requirements and positioned them not just to meet the immediate 18-month deadline but also to lay a solid foundation for the company’s long-term success. The Interim CIO’s approach was multifaceted and included:
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strategic planning,
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roadmap development,
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data governance, and
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meticulous project execution.
One of the first critical steps was the development of a comprehensive IT Strategic Plan, complete with a 5-year budget and forecast for all company sites. This initiative established a central IT budget and tracked historical IT spending to provide a clear roadmap for future investments and ensure IT resources aligned with the company’s growth objectives.
To ensure seamless integration, the Interim CIO developed a detailed IT roadmap and project plan that integrated with the new site. This meant systems and technologies were implemented and validated in a specific, logical sequence designed to meet all regulatory requirements, minimizing potential conflicts and ensuring compliance.
Recognizing that data is the lifeblood of any modern enterprise, especially in biotech, the Interim CIO formed a dedicated team to define a product data schema and hierarchy for the BatchMaster ERP (Enterprise Resource Planning) system. This initiative led to the classification of 1600 items that:
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significantly improved data accessibility and
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enabled more efficient product release and distribution.
By establishing clear data governance, the company could now leverage its information assets more effectively: transform information to actionable insights.
The core of the Interim CIO’s success lay in the precise execution of the ambitious 18-month project plan. This involved several critical implementations:
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Network and Infrastructure: Within a remarkable four weeks, a Managed Services and Security Provider (MSSP) was selected to build the plant’s foundational infrastructure.
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eQMS Implementation: An electronic Quality Management System (TrackWise Digital) was implemented and validated for managing SOPs, work instructions, and validation documents.
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CMMS Installation: A Computerized Maintenance Management System (Blue Mountain) was installed and validated for equipment calibration and maintenance.
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ERP Selection and Implementation: The BatchMaster Manufacturing add-on to SAP Business One was evaluated, selected, implemented, and validated within the stringent timeline while providing a robust financial management.
The Transformative Results: A Testament to Strategic Leadership
The results of the Interim CIO’s engagement were nothing short of transformative. All systems required for the new site to operate the plant were not only implemented but also validated within the aggressive 18-month deadline. This monumental achievement positioned the company to meet the rigorous quality and regulatory standards of the pharmaceutical industry, a non-negotiable prerequisite for their continued success and future growth.
The Biotech COO acknowledged this initiative: “Fortium’s CIO was a strong business partner at a biotech company under PE ownership; I was COO with a Fortium CIO as my partner. The CIO’s IT skill set was broad and flexible, for she presented a strategic conceptual systems perspective to both architecture and implementation work, understood both IT and OT roles and could manage at the Board level as capably as resolving a field-level data issue. The Interim CIO brought dedication and focus to the task and drive to closure. She was a pleasure to work with and get to know.” This glowing endorsement highlights the Interim CIO’s multifaceted capabilities, from strategic vision to hands-on problem-solving, and their ability to be a true partner in achieving business objectives.
Partnering for Success: Your Path to Operational Excellence
The case study illustrates the impact of strategic IT leadership in navigating complex challenges and achieving ambitious goals. Fortium Partners specializes in providing top-tier interim and fractional IT executives who can drive similar transformations within your organization. Whether you’re facing aggressive deadlines, resource constraints, or the need for a comprehensive IT overhaul, our partners bring the expertise and dedication to deliver exceptional results.
Are you ready to accelerate your company’s growth and achieve operational excellence?
Contact Fortium Partners today to learn how our interim CIOs can empower your business to meet its most ambitious objectives.
