Job ID: JOB_ID_2148
Role Overview
We are seeking a highly skilled and experienced Lead Business Analyst with deep expertise in Veeva Vault QMS to join a long-term project in West Point, PA. This hybrid role requires 2 to 3 days onsite per week, collaborating with cross-functional teams to drive digital transformation within the life sciences sector. The ideal candidate will serve as a Subject Matter Expert (SME) for Quality Management Systems, specifically focusing on end-to-end process design, configuration support, and deployment for core QMS processes such as Deviations, CAPA, and Audits.
Key Responsibilities
- Lead and facilitate cross-functional business SME groups to drive alignment on complex requirements and design decisions.
- Elicit, analyze, and document comprehensive business requirements, user stories, and acceptance criteria for Veeva Vault solutions.
- Define global ‘to-be’ processes, harmonizing site-specific or functional variations into standardized, simplified workflows.
- Develop and maintain high-quality QMS documentation, including SOPs, Work Instructions, Job Aids, and training materials.
- Collaborate closely with Agile delivery teams, product owners, and validation experts to ensure high-quality deliverables.
- Manage the full SDLC lifecycle, from initial requirement gathering through to configuration, testing, and release.
- Utilize JIRA and related tools to manage traceability, status updates, and leadership reporting.
Technical and Domain Expertise
- Deep expertise in Veeva Vault QMS configuration and deployment.
- Strong knowledge of GxP, regulatory, and validation requirements (GMP/GCP/GLP).
- Proven experience in process mapping and modeling using workflows, swimlanes, and SIPOC methodologies.
- Expertise in Deviations and CAPA management within a regulated life sciences environment.
- Experience with enterprise content management tools like SharePoint and Confluence for version control and publication.
Professional Qualifications
The successful candidate must demonstrate a proven track record as a Lead Business Analyst on multiple large-scale QMS implementations. Excellent communication and stakeholder management skills are essential, as you will be responsible for translating complex business needs into actionable technical specifications. You must be adept at navigating the complexities of a regulated industry, ensuring all documentation is audit-ready and compliant with global standards. This role offers the opportunity to influence the digital landscape of a major pharmaceutical implementation through process transformation and standardization.
Special Requirements
Hybrid 2-3 days onsite. Restriction: Candidates already submitted to HCL America will not be considered.
Compensation & Location
Salary: $135,000 – $178,000 per year (Estimated)
Location: West Point, PA
Recruiter / Company – Contact Information
Recruiter / Employer: KTEK Resourcing
Email: mansi.sen@ktekresourcing.com
Recruiter Notice:
To remove this job posting, please send an email from
mansi.sen@ktekresourcing.com with the subject:
DELETE_JOB_ID_2148