
Senior Business Analyst – Pharmaceutical Manufacturing
Minor Hotels Europe and Americas
full-time
Posted on:
Location Type: Hybrid
Location: Gaithersburg • Maryland • United States
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Salary
💰 $125,000 - $192,000 per year
Job Level
About the role
- Partner with product/program management, engineering, data, QA, compliance, and vendor teams to gather and clarify business, scientific, and operational needs.
- Translate complex CMC/experimentation workflows into clear, testable functional and non-functional requirements and user stories.
- Define data models, interfaces, and information flows needed to enable compliant, high-quality experimentation.
- Lead/coordinate implementation of new COTS and SaaS solutions aligned to regulatory requirements.
- Configure capabilities, define integrations, and align platform features to business outcomes.
- Establish success metrics/KPIs and ensure value realization from the platform and workflows.
- Support backlog prioritization, release planning, and readiness (incl. change management and training inputs).
- Ensure processes and requirements align with applicable GxP/QA and data integrity expectations.
- Partner with QA/compliance to embed controls, auditability, and validation considerations.
- Leverage SAFe methodology and ceremonies (PI planning, backlog refinement, sprint reviews), and maintain high-quality artifacts (epics/features/stories, acceptance criteria) to support User Acceptance Testing.
- Coordinate with vendors on solution design, issues, and roadmap alignment.
- Communicate status, risks, and decisions to cross-functional stakeholders.
Requirements
- 5+ years of documented experience in a business analyst or PMO role in pharmaceutical or life sciences organizations
- Hands-on experience implementing or working with commercial (COTS/SaaS) platforms—ideally in laboratory, bioprocess, or experimentation domains
- Demonstrated delivery within regulated environments with QA/compliance collaboration
- Practical experience working in SAFe/Agile-at-scale programs
- Familiarity with validation, data integrity, and GxP considerations for SaaS/COTS implementations
- Strong understanding of CMC/life sciences workflows and associated data/process needs
- Excellent stakeholder management, facilitation, and communication skills.
Benefits
- Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade
- Company paid holidays
- Personal Days
- Sick Leave
- Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
- Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
- Life and disability insurance
- Employee assistance programs
- Other benefits as provided by local policy and eligibility
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
data modelsfunctional requirementsnon-functional requirementsuser storiessuccess metricsKPIchange managementvalidationdata integrityGxP
Soft Skills
stakeholder managementfacilitationcommunication