Specialist IS Business Analyst
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Career Category
Information Systems
Job Description
Position Summary
Lead the validation team in a GMP High Salesforce application and serve as the accountable leader for validation governance, GxP compliance, RTM traceability, inspection readiness, and quality oversight. Drive compliant delivery through strong validation leadership, risk-based decision making, and operational excellence while developing a high-performing validation team.
Key Responsibilities
Lead validation strategy, governance, and execution for GxP-regulated applications, computerized systems, and digital platforms.
Ownership & oversight for validation activities, ensuring compliance with internal SOPs, regulatory requirements, and industry standards.
Author & ownership of validation deliverables including Validation Plans, Risk Assessments, IQ/OQ/PQ Protocols, Validation Summary Reports (VSRs), and Requirements Traceability Matrices (RTMs).
Establish and maintain end-to-end traceability between requirements, risks, test evidence, defects, and compliance documentation through RTM governance.
Ensure inspection of readiness and support internal audits, regulatory inspections, CAPA, deviation management, and change control activities.
Complete ownership of validation strategy, testing scope and end-to-end system validation.
Lead and mentor Validation Engineers, establishing best practices and driving a quality-first culture.
Partner with Product, Business, Quality, Regulatory, and Technology teams to support compliant and timely delivery of business initiatives.
Drive continuous improvement initiatives to reduce validation cycle time while maintaining compliance and quality standards.
Basic Qualifications
Bachelor's or Master's degree in Computer Science, Engineering, Information Systems, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline.
8+ years of experience in Computer System Validation (CSV), Quality Assurance, or GxP-regulated environments.
3+ years of experience leading validation teams, validation programs, or quality compliance initiatives.
Experience supporting regulated systems throughout the software development lifecycle (SDLC).
Preferred Qualifications
Experience leading validation activities for global, enterprise-scale digital platforms.
Experience implementing Computer Software Assurance (CSA) and risk-based validation methodologies.
Experience validating cloud-based and SaaS platforms.
Experience supporting Agile and product-centric delivery organizations.
Experience driving validation automation and digital transformation initiatives in Life Sciences domain.
Required Skills
Computer System Validation (CSV) expertise.
Strong knowledge of GxP regulations, FDA 21 CFR Part 11, Annex 11, and Data Integrity requirements.
Validation lifecycle management including Validation Plans, Risk Assessments, RTM, IQ/OQ/PQ, and VSRs.
Requirements Traceability Matrix (RTM) creation, governance, and compliance management.
Risk-based validation and test strategy development.
Audit and inspection readiness management.
Quality Management Systems (QMS), CAPA, deviation, and change control processes.
Validation management tools such as ALM, Jira, Validation Management (VM), or equivalent platforms.
Good-to-Have Skills
Computer Software Assurance (CSA).
GAMP 5 methodology.
Validation of Salesforce, Mulesoft, cloud, and SaaS solutions.
Automated testing and validation frameworks.
DevOps, CI/CD, and release management practices.
Quality metrics, KPI reporting, and trend analysis.
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Job details
How this role compares
Computed from every other active Information Technology role in our database, not just this employer's listings.
We currently track 1167 comparable Information Technology roles across 74 biopharma companies.
Salary context
162 of 1167 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1167 comparable roles
+ 29 more countries
Seniority mix
667 of 1167 peers have a known seniority level
Therapeutic area mix
2 of 1167 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.