Sr. Analyst (ALM), Digital Quality

How you will make an impact:

• System enhancement management: Manages and monitors enhancement request backlog for Application Lifecycle Management (ALM).
• Requirement analysis and management: Act as the primary business analyst and process liaison for the ALM platform by partnering with cross-functional stakeholders to capture business needs and convert them into clear system requirements, functional specifications, workflows, reports, and configuration requests.
• Lead requirements elicitation, analysis, documentation, prioritization, and traceability activities for ALM capabilities, including requirements management, risk management, test management, review and approval workflows, baseline management, and reporting.
• Partner with Quality, R&D, Manufacturing, Software Quality, Validation, IT, and vendor teams to ensure ALM processes align with business requirements, regulatory expectations, and applicable quality system procedures.
• Support configuration design by defining tracker structures, attributes, lifecycle states, approval workflows, role-based access needs, templates, dashboards, and reporting requirements.
• Analyze current-state processes and identify opportunities to streamline, standardize, and optimize ALM workflows, reducing manual effort while improving compliance, usability, and traceability.
• Develop and maintain business process documentation, requirements documents, user stories, test scenarios, training materials, work instructions, job aids, and knowledge base content.
• Ensure defined test strategy and test plans adequately cover the requirements.
• Support user acceptance testing, defect triage, traceability reviews, evidence collection, and validation documentation reviews.
• Facilitate workshops, design sessions, stakeholder reviews, and decision discussions to gain alignment on business process design and system functionality.
• Collaborate with technical teams to troubleshoot system issues, clarify business impacts, support root cause analysis.
• Drive user adoption through training, communication, super-user engagement, best practice sharing, and ongoing support for business users.
• Support governance activities, including change impact assessments, enhancement intake, prioritization, release planning, access reviews, and process compliance monitoring.
• Act as a mentor or knowledge resource for business analysts, project team members, and super-users supporting the ALM platform.

What you'll need (Required):

• Bachelor's degree in computer science, information systems, engineering, business administration, or a related field with 5 years' experience or
• Master's degree, with 3 years' experience in an analyst, business systems analyst, product owner, or similar role supporting enterprise systems.

What else we look for (Preferred):

• Experience managing small projects
• Experience working in a medical device, life sciences, pharmaceutical, or other regulated industry.
• Ability to adapt to new technology and a rapidly changing environment.
• Ability to interface and manage multiple stakeholders.
• Result Oriented, positive "can-do" mindset with demonstration of appropriate urgency and initiative
• Experience in medical devices, pharma, biotech or healthcare related industries.
• Understanding of business analysis practices, including requirements elicitation, process mapping, stakeholder analysis, gap analysis, and solution documentation.
• Knowledge of SDLC, ALM concepts, Agile practices, requirements traceability, change control, and software validation principles.
• Experience supporting ALM, PLM, EQMS, SDLC, validation, requirements management, test management, or regulated system implementation initiatives.
• Experience drafting presentations and presenting investigation and trend summaries.
• Understanding of regulated system expectations, including 21 CFR Part 11, GxP, computer system validation, audit trails, electronic signatures, and good documentation practices.
• Strong analytical, problem-solving, organizational, and critical thinking skills with attention to detail.
• Excellent written and verbal communication skills, including the ability to communicate with technical and non-technical audiences.
• Strong facilitation skills with the ability to lead workshops, drive decisions, and build alignment across cross-functional teams.
• Ability to manage competing priorities, work independently with minimal supervision, and deliver high-quality documentation in a fast-paced environment.
• Proficiency with Microsoft Office tools, including Word, Excel, PowerPoint, Teams, and SharePoint.