Position Overview
We are seeking a seasoned Senior Business Analyst / Subject Matter Expert (SME) with deep expertise in the pharmaceutical domain, particularly portfolio management, project governance, and Quality Management Systems (QMS), to support the design and development of enterprise software products for the pharma and life sciences industry.
This role plays a critical part in shaping product vision, requirements, compliance alignment, and customer value, ensuring that software products meet regulatory standards, industry best practices, and real-world pharma business needs.
Key Responsibilities
Product & Domain Leadership (Pharma SME) :
- Act as a pharma domain SME for software product development initiatives.
- Provide expert guidance on pharma portfolio management, quality processes, and compliance expectations.
- Translate real-world pharma operational workflows into scalable, configurable software product capabilities.
- Support product roadmap definition aligned with pharma customer needs and regulatory requirements.
Requirements & Product Analysis
- Gather, analyze, and document product-level functional and non-functional requirements.
- Convert pharma business needs into:
- Epics, features, and user stories.
- Acceptance criteria and traceability matrices.
- Ensure requirements support multi-tenant, configurable product design rather than one-off solutions.
Pharma Portfolio & Project Management
- Provide domain expertise for pharma portfolio management modules (initiative prioritization, stage-gates, lifecycle management, metrics).
- Define requirements for project planning, governance, resource tracking, milestones, and reporting within the product.
- Ensure alignment with industry-standard portfolio and project management practices used in pharma organizations.
QMS & Regulatory Compliance
- Define and validate product requirements for QMS functionalities, including:
- Change Control.
- Deviations & CAPA.
- Document & Training Management.
- Audit & Inspection Management.
- Ensure the product supports compliance with GxP, FDA, EMA, ICH, ISO standards, and 21 CFR Part 11.
- Support computer system validation (CSV) expectations by defining validation-ready requirements and documentation.
- Review product workflows to ensure audit readiness and data integrity (ALCOA+ principles).
Agile Product Development Support
- Work closely with Product Managers, Architects, UX designers, and Engineering teams in Agile/Scrum environments.
- Participate in backlog grooming, sprint planning, reviews, and retrospectives.
- Clarify domain-specific scenarios, edge cases, and compliance impacts during development.
- Support UAT and customer pilots from a domain and compliance perspective.
Stakeholder Collaboration
- Act as a bridge between pharma customers, internal product teams, quality experts, and regulatory stakeholders.
- Facilitate workshops, demos, and requirement walkthroughs with internal and external stakeholders.
- Support pre-sales, customer onboarding, and product adoption by articulating pharma value propositions.
Required Skills & Qualifications
- Bachelors or Masters degree in Life Sciences, Pharmacy, Engineering, IT, or related field.
- 5+ years of experience in the pharmaceutical or life sciences domain, with significant exposure to software or digital product development.
- Strong hands-on experience in:
- Pharma portfolio management.
- Project / Program Management.
- Quality Management Systems (QMS).
- Deep understanding of GxP regulations, compliance, and validation requirements.
- Proven experience translating regulatory and business needs into product requirements.
Preferred Qualifications
- Experience working on commercial pharma software products (QMS, PPM, R&D systems, manufacturing systems).
- Hands-on exposure to QMS platforms (Veeva Vault, TrackWise, MasterControl, SAP QM).
- Familiarity with Agile product development in regulated environments.
- Certifications such as PMP, SAFe, CSM, or Pharma Quality certifications.
- Experience supporting CSV, audit readiness, and inspections.
Soft Skills
- Strong domain storytelling and ability to articulate pharma workflows clearly.
- Excellent stakeholder management and communication skills.
- Strategic mindset with attention to regulatory detail.
- Ability to mentor product teams and influence product direction.
Key Outcomes Expected
- Pharma-compliant, validation-ready software product features.
- Clear, scalable product requirements aligned with customer and regulatory needs.
- Reduced compliance risk through strong domain and QMS alignment.
- Accelerated product adoption within pharma customers.
Career Path
- Growth opportunities into Principal SME, Product Owner (Pharma), Product Manager, or Domain Lead roles.
(ref:hirist.tech)
