Business Analyst with CSV

Job Title

Analyze and evaluate current business processes, anticipate future requirements, identify areas for improvement, and develop and implement effective solutions. Utilize both formal and informal communication methods to stay updated on customer needs and strategies. Communicate updates and findings effectively through project meetings and presentations to diverse audiences, including business and cross-functional partners, application users, and business leadership stakeholders. Share ideas and findings through well-organized meetings and presentations. Analyze requirements and produce detailed documentation, including as-is and to-be process flow diagrams, information flow diagrams, system RACI tables, and business requirements specifications. Ensure that solutions meet business needs and requirements, and effectively communicate insights and plans to cross-functional team members and management. Collect essential information from meetings with various stakeholders, working closely with clients, technicians, and managerial staff. Document and communicate the outcomes of your efforts clearly and effectively. Offer leadership, training, coaching, and guidance to junior staff members. Develop and maintain strong relationships with stakeholders to ensure alignment and support for business initiatives. Identify and mitigate risks associated with business processes and projects. Analyze data to identify trends and insights that inform business decisions. Collaborate with IT teams to ensure clear communication. Create and maintain comprehensive documentation for all business processes and systems. Provide post-implementation support and troubleshooting processes. Ensure compliance with industry regulations and standards in all business processes. Improve the effectiveness and efficiency of the existing CSV delivery model through the creation of various templates, tools, training courses, and the periodic collection of KPI metrics. Contribute to operational and process improvement initiatives related to Quality and Compliance. Apply CSV expertise to make significant contributions to specific business units or departments. Interpret and execute company policies and procedures, recommending modifications to operating policies. Work closely with other validation team members to ensure system impact is assessed and mitigation strategies are in place for multiple sites.

Skills and Qualifications

7+ years of business analysis experience. 5+ years of experience in the pharmaceutical industry. A bachelor's degree in business or a related field, or an MBA. Exceptional analytical and conceptual thinking skills. Ability to influence stakeholders and work closely with them to determine acceptable solutions. Excellent presentation and customer workshop leadership skills. Excellent documentation skills. Experience creating detailed reports and giving presentations. Competency in Microsoft applications including Word, Excel, and Outlook. A track record of following through on commitments. Excellent planning, organizational, proactive, and time management skills. Experience leading and developing top-performing teams. A history of leading and supporting successful projects. Advanced knowledge and expertise in Computer System Validation (CSV), FDA & international requirements, and Part 11 requirements. Experience writing validation deliverables per GAMP guidelines. Experience working in CSV field and GMP pharmaceutical/biotechnology/medical device environments.