Senior Business Systems Analyst, Quality & Supply Chain Systems

This is a fully remote position, open to applicants in Tennessee, +1 more state.

📋 Description

• Collaborate with stakeholders from Quality, Manufacturing, Supply Chain, and IT to establish business requirements and solution strategies.

• Facilitate workshops for requirements gathering, process mapping sessions, and interviews with stakeholders.

• Convert business priorities into comprehensive functional and technical requirements.

• Enhance and support Quality Management Systems, encompassing CAPA, Change Control, Deviations, Non-Conformance Management, Document Control, and Audit Management.

• Analyze business processes and pinpoint opportunities for automation, standardization, and digital transformation.

• Evaluate the impacts, risks, integrations, and readiness for deployment of solutions across enterprise platforms.

• Assist in User Acceptance Testing, validation processes, and change management initiatives.

• Work alongside project teams to provide compliant, scalable, and secure technology solutions that align with business objectives.

• Some travel may be necessary based on business requirements.

• Engage in meetings, workshops, and system testing activities using standard technological tools.

⛳️ Requirements

• Bachelor's degree or equivalent with typically over 7 years of pertinent experience.

• Proven experience in gathering, documenting, and managing business and system requirements.

• Background in supporting Quality Management Systems (QMS), including CAPA, Change Control, Deviations, Non-Conformance Management, Document Control, and Audit Management.

• Familiarity with end-to-end Supply Chain IT systems, including planning, procurement, manufacturing, inventory, logistics, or distribution processes.

• Capability to facilitate stakeholder workshops and ensure alignment of requirements across various teams.

• Experience in supporting User Acceptance Testing (UAT) and activities related to solution deployment.

• Excellent communication, analytical, problem-solving, and stakeholder management skills.

• Experience working in GMP, GxP, pharmaceutical, medical device, healthcare, or regulated manufacturing environments.

• GMP certification or proven experience within GMP-regulated organizations.

• Familiarity with ERP, MES, Quality, Manufacturing, or Supply Chain technology platforms.

• Understanding of SDLC, validation, risk assessment, and compliance processes.

• Experience in business process automation, workflow optimization, and digital transformation initiatives.

• Knowledge of predictive analytics, process modeling, and reporting tools.

• Proven ability to influence cross-functional stakeholders and enterprise-level initiatives.

• Advanced degree and/or relevant industry certifications.

🏝️ Benefits

• Potential for annual bonuses or long-term incentive opportunities.

• Competitive compensation package offered.

• Hybrid or remote work options available.

• Commitment to equal employment opportunities.

• Reasonable accommodations provided for job searches or applications.