Katalyst CRO ยท 4 weeks ago
Sr. Business Analyst
Chicago, IL
Contract
Onsite
Senior LevelKatalyst Healthcares & Life Sciences is focused on enhancing global Rapid Diagnostics distribution processes. The Sr. Business Analyst will lead initiatives to improve operational efficiency and ensure compliance with international regulatory standards while fostering collaboration across various teams.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Develop a deep understanding of global Rapid Diagnostics distribution processes, systems, and business programs to identify operational risks, inefficiencies, and opportunities for improvement
Lead the creation, implementation, and continuous improvement of standard operating procedures (SOPs) and work instructions to ensure consistent, high-quality operations across global sites and also involve in the documentation of the process
Oversee the implementation and maintenance of quality systems related to Rapid Diagnostics distribution, including documentation control, deviation management, CAPA, and change control processes
Ensure compliance with international regulatory standards, including FDA (21 CFR), EMA, MHRA, WHO GDP, and local health authorities, by aligning distribution practices with evolving global requirements
Foster strong cross-functional collaboration with supply chain, quality assurance, regulatory affairs, legal, and commercial teams to support integrated compliance efforts and business alignment
Identify and lead initiatives to resolve process and system gaps that may impact product quality, regulatory compliance, or operational efficiency
Leverage and optimize distribution technologies, such as SAP, warehouse management systems (WMS), and monitoring tools, to enhance visibility, traceability, and performance
Collaborate with global partners, internal teams, and third-party logistics providers to coordinate distribution activities, resolve challenges, and ensure timely, compliant delivery of Client products
Act as a liaison between business, regulatory, and technical teams, translating operational needs into actionable strategies and ensuring alignment across global operations
Author, review, and approve CSV and quality deliverables, including vendor assessments, system risk assessments, validation plans, requirements specifications, IQ/OQ/PQ protocols, traceability matrices, summary reports, and relevant SOPs
Optimize distribution and quality technologies such as SAP, Warehouse Management Systems (WMS), Win shuttle, and Docusign to enhance traceability, audit readiness, and operational performance while maintaining GxP compliance
Collaborate with clients to deliver demos and identify high-value digital applications that support their business needs, while ensuring the design and implementation of solutions adhere to regulatory standards within GxP environments
Qualification
Required
Develop a deep understanding of global Rapid Diagnostics distribution processes, systems, and business programs to identify operational risks, inefficiencies, and opportunities for improvement
Lead the creation, implementation, and continuous improvement of standard operating procedures (SOPs) and work instructions to ensure consistent, high-quality operations across global sites and also involve in the documentation of the process
Oversee the implementation and maintenance of quality systems related to Rapid Diagnostics distribution, including documentation control, deviation management, CAPA, and change control processes
Ensure compliance with international regulatory standards, including FDA (21 CFR), EMA, MHRA, WHO GDP, and local health authorities, by aligning distribution practices with evolving global requirements
Foster strong cross-functional collaboration with supply chain, quality assurance, regulatory affairs, legal, and commercial teams to support integrated compliance efforts and business alignment
Identify and lead initiatives to resolve process and system gaps that may impact product quality, regulatory compliance, or operational efficiency
Leverage and optimize distribution technologies, such as SAP, warehouse management systems (WMS), and monitoring tools, to enhance visibility, traceability, and performance
Collaborate with global partners, internal teams, and third-party logistics providers to coordinate distribution activities, resolve challenges, and ensure timely, compliant delivery of Client products
Act as a liaison between business, regulatory, and technical teams, translating operational needs into actionable strategies and ensuring alignment across global operations
Author, review, and approve CSV and quality deliverables, including vendor assessments, system risk assessments, validation plans, requirements specifications, IQ/OQ/PQ protocols, traceability matrices, summary reports, and relevant SOPs
Optimize distribution and quality technologies such as SAP, Warehouse Management Systems (WMS), Win shuttle, and Docusign to enhance traceability, audit readiness, and operational performance while maintaining GxP compliance
Collaborate with clients to deliver demos and identify high-value digital applications that support their business needs, while ensuring the design and implementation of solutions adhere to regulatory standards within GxP environments
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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