Business Analyst Lead

Employment Eligibility Statement

Due to specific project and client requirements, this position is open to U.S. Citizens and U.S. Lawful Permanent Residents (s). Sponsorship is not available at this time.

Danta Technologies evaluates all candidates in compliance with the Immigration and Nationality Act (INA) and EEOC guidelines. All hiring decisions are made without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic.

We are seeking an experienced Lead Business Analyst / Configure & Design Lead with deep expertise in Veeva Vault QMS to support end-to-end QMS process design, configuration, and deployment.

This role is ideal for a strong QMS domain expert who thrives at the intersection of Business, Quality, and Technology, and can confidently lead workshops, drive stakeholder alignment, and translate complex requirements into scalable system solutions.

Note:
This role is located in West Point, PA and follows a hybrid work model, requiring 2–3 days onsite each week. The position is available to eligible candidates local to West Point, PA only.

Must Have Experience:

• Deep expertise in Veeva Vault QMS, including end-to-end process design, configuration support, and deployment for core QMS processes.
• QMS business domain SME with strong knowledge of end-to-end Deviations and CAPA management, and GMP/Google Cloud Platform/GLP Audits & Inspections processes.
• Serve as the primary liaison between technical and non‐technical teams, translating complex technical concepts into clear, business‐friendly language to help stakeholders understand impacts, timelines, risks, and requirements.
• Define workshop objectives, coordinate scheduling, prepare materials, facilitate the sessions, document key decisions and outcomes, and distribute meeting notes to ensure alignment and follow‐through.
• Identify and engage all relevant stakeholders across Business, IT, Quality, IAM, Integration teams, and external vendors. Drive effective communication, alignment, and timely decision-making. Monitor approvals, manage dependencies, assess cross‐functional impacts, and escalate risks or issues as necessary to keep the program on track.
• Expertise in eliciting, analyzing, and documenting business requirements, user stories, use cases, and acceptance criteria for complex QMS solutions.
• Experience working in Agile delivery models, collaborating closely with product owners, technical teams, and QA/validation to refine backlogs and ensure high-quality deliverables.
• Strong understanding of GxP, regulatory, and validation requirements related to electronic QMS solutions, including impact on requirements, testing, and documentation.
• Excellent communication and stakeholder management skills, able to translate business needs into clear, actionable specifications and facilitate workshops and decision-making sessions

Job Description:

• Strong understanding of GxP, regulatory, and validation requirements related to electronic QMS solutions, including impact on requirements, testing, and documentation.
• Excellent communication and stakeholder management skills, able to translate business needs into clear, actionable specifications and facilitate workshops and decision-making sessions.
• Proficiency with JIRA and related tools for managing requirements, user stories, traceability, and status, as well as preparing clear business-facing and leadership updates.
• Strong technical writing experience for Veeva Vault QMS, including creation and maintenance of process, system, and user documentation.
• Subject matter expertise in QMS processes, specifically Deviations and CAPA, with the ability to accurately translate SME input into clear, structured documentation.
• Experience developing QMS documentation and supporting SDLC activities (requirements, functional specifications, configuration documents, test scripts, release notes, user guides).
• Proficiency in business process mapping and modeling (e.g., workflows, swimlanes, SIPOC), and converting process maps into readable, role-based procedures and work instructions.
• Skilled in content creation for a regulated environment, including SOPs, Work Instructions, Job Aids, Quick Reference Guides, training materials, and FAQs.
  Strong familiarity with GxP, quality, and regulatory requirements to ensure documentation is complete, compliant, and audit-ready.

Notes:- All qualified applicants will receive consideration for employment without regard to race, color, religion, religious creed, sex, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, military and veteran status, marital status, pregnancy, gender, gender expression, gender identity, sexual orientation, or any other characteristic protected by local law, regulation, or ordinance.

Benefits: Danta offers a compensation package to all W2 employees that are competitive in the industry. It consists of competitive pay, the option to elect healthcare insurance (Dental, Medical, Vision), Major holidays and Paid sick leave as per state law.

The rate/ Salary range is dependent on numerous factors including Qualification, Experience and Location.