Sr Quality Systems Analyst
Bristol Myers Squibb
5 days ago
Remote friendly (New Brunswick, NJ)
United States
Operations
Position Overview:
The Technical Business Analyst serves as a link between Digital Technology teams and business stakeholders, translating business needs into technical solutions, guiding moderately complex technology initiatives, and contributing to mid-scale digital programs from concept to execution.
Key Responsibilities:
- Translate functional needs into actionable business requirements.
- Lead elicitation, analysis, documentation, and validation of user requirements.
- Partner with stakeholders and cross-functional teams; serve as a liaison between business units and technical delivery teams.
- Develop and maintain business process models, conceptual data models, and system requirements artifacts.
- Establish/maintain requirement baselines with traceability to regulatory, compliance, and quality standards.
- Participate in solution design discussions; define requirements management and change control approach.
- Provide end-to-end solution ownership and value realization.
- Lead architecture/integration impact assessment (APIs, data flows, non-functional requirements).
- Lead regulatory/validation requirements (GxP, Part 11, data integrity) with Validation/Quality.
- Influence program-level dependencies, risks, and alignment with enterprise digital/quality strategy.
- Support Agile delivery, including epic-level ownership/backlog strategy aligned to regulated SDLC.
- Support planning; manage evolving requirements with PMs; identify/escalate requirement risks.
- Evaluate solution options for business case development and technology adoption.
Required Qualifications:
- BS/MS in CS, Engineering, or related technical field.
- 5+ years project-level business analysis (e.g., requirements sessions, process modeling, conceptual data modeling, use cases/wireframes).
- 3–5 years program-level business analysis leadership.
- 3–5 years supporting digital transformation.
- Strong documentation/tooling: business process, process flow analysis, requirements definition, data models, functional design, executive summaries.
- Agile project management knowledge; end-to-end application management.
- Cross-functional collaboration incl. developers and compliance teams.
- Strong analytics, stakeholder management, facilitation/influencing.
- MS Project/Word/PowerPoint/Excel; excellent written/verbal English.
Desired Skills:
- LIMS or bioinformatics; GMP/GxP/FDA/IEC 62304 familiarity.
- Test-driven development, continuous integration; data science/statistical analysis (R) plus.
- Azure/AWS and DevOps tools preferred.
Compensation/Benefits (if part of posting):
- New Brunswick, NJ, US: $137,530–$166,654.
- Health coverage; wellbeing support; 401(k); disability/life insurance and related protections.
Application Instructions:
- Apply; no additional instructions provided in the excerpt.
The Technical Business Analyst serves as a link between Digital Technology teams and business stakeholders, translating business needs into technical solutions, guiding moderately complex technology initiatives, and contributing to mid-scale digital programs from concept to execution.
Key Responsibilities:
- Translate functional needs into actionable business requirements.
- Lead elicitation, analysis, documentation, and validation of user requirements.
- Partner with stakeholders and cross-functional teams; serve as a liaison between business units and technical delivery teams.
- Develop and maintain business process models, conceptual data models, and system requirements artifacts.
- Establish/maintain requirement baselines with traceability to regulatory, compliance, and quality standards.
- Participate in solution design discussions; define requirements management and change control approach.
- Provide end-to-end solution ownership and value realization.
- Lead architecture/integration impact assessment (APIs, data flows, non-functional requirements).
- Lead regulatory/validation requirements (GxP, Part 11, data integrity) with Validation/Quality.
- Influence program-level dependencies, risks, and alignment with enterprise digital/quality strategy.
- Support Agile delivery, including epic-level ownership/backlog strategy aligned to regulated SDLC.
- Support planning; manage evolving requirements with PMs; identify/escalate requirement risks.
- Evaluate solution options for business case development and technology adoption.
Required Qualifications:
- BS/MS in CS, Engineering, or related technical field.
- 5+ years project-level business analysis (e.g., requirements sessions, process modeling, conceptual data modeling, use cases/wireframes).
- 3–5 years program-level business analysis leadership.
- 3–5 years supporting digital transformation.
- Strong documentation/tooling: business process, process flow analysis, requirements definition, data models, functional design, executive summaries.
- Agile project management knowledge; end-to-end application management.
- Cross-functional collaboration incl. developers and compliance teams.
- Strong analytics, stakeholder management, facilitation/influencing.
- MS Project/Word/PowerPoint/Excel; excellent written/verbal English.
Desired Skills:
- LIMS or bioinformatics; GMP/GxP/FDA/IEC 62304 familiarity.
- Test-driven development, continuous integration; data science/statistical analysis (R) plus.
- Azure/AWS and DevOps tools preferred.
Compensation/Benefits (if part of posting):
- New Brunswick, NJ, US: $137,530–$166,654.
- Health coverage; wellbeing support; 401(k); disability/life insurance and related protections.
Application Instructions:
- Apply; no additional instructions provided in the excerpt.