Job
Description
Milestone is seeking a Lead Business Systems Analyst to drive the successful delivery of technology and process solutions across manufacturing, laboratory, and enterprise systems in a dynamic biopharma environment. This role acts as a key liaison between business stakeholders, IT teams, and third-party vendors, ensuring that business needs are translated into effective and compliant technology solutions. The ideal candidate possesses a blend of analytical and project management skills, has deep familiarity with regulated environments (e.g., GxP), and excels at facilitating cross-functional collaboration. This is a hands-on position requiring strong communication, technical documentation, and Agile leadership capabilities. Key Responsibilities Lead the requirements gathering process through stakeholder interviews, workshops, and system documentation. Translate complex business needs into detailed user stories, use cases, process flows, and system specifications. Facilitate Agile ceremonies (stand-ups, sprint planning, retrospectives) across one or more delivery teams. Partner with QA/validation teams to define test strategies and support validation protocols, including UAT coordination. Coordinate activities related to change controls, CAPAs, SOP documentation, and release processes in accordance with regulatory standards. Support configuration of business applications, including parameterization and minor setup changes where applicable. Maintain detailed and organized documentation: meeting notes, training materials, wireframes, and decision logs. Work with product owners, lab stakeholders, and infrastructure teams to support lifecycle activities of lab and manufacturing systems. Coordinate with vendors and internal teams on deployment and integration activities in test and production environments. Conduct impact assessments and risk analyses for proposed system changes. Act as a central point of contact for M&A system integration activities, security infrastructure documentation, and GxP alignment when applicable. Utilize collaborative tools such as Lucidchart, Miro, MS Teams, JIRA, Confluence, and others to support project communication and workflow visualization. Provide technical writing support for SOPs, policy documents, and training guides. Qualifications Required: Bachelors degree in Computer Science, Information Systems, Life Sciences, or a related field. 8+ years of experience in IT business analysis, systems analysis, or project coordination preferably within biotechnology, pharmaceuticals, or a regulated industry. Strong understanding of biotech manufacturing and lab workflows and their associated systems. Demonstrated experience in Agile methodologies and tools (e.g., Scrum, Kanban, JIRA). Proven ability to manage multiple concurrent workstreams with minimal supervision. Excellent written and verbal communication skills, particularly in remote or hybrid settings. Familiarity with system validation and compliance standards in a regulated (e.g., GxP) environment. Preferred: Experience coordinating with Infrastructure, Security, or M&A teams. Working knowledge of technical domains such as IAM, data protection, firewalls, or cloud services (e.g., AWS, Azure). Certifications related are a plus. Proficiency in documentation tools such as MS Word, PowerPoint, Excel, Teams, Smartsheets, Jira and visualization platforms like Lucidchart or Visio. Soft Skills Strong critical thinking and problem-solving skills. Highly organized with the ability to prioritize and manage deadlines. Ability to navigate cross-functional teams and drive alignment across stakeholders. Comfortable working in ambiguous, fast-paced environments with evolving requirements
