Fractional VP of Quality Enables Scalable Compliance and ISO 27001 Certification
The Challenge
A regulated SaaS vendor serving pharmaceutical clients faced growing compliance requirements tied to GxP, security, and client validation expectations. While the organization had a strong product foundation and customer demand, it needed to formalize its quality and security practices to support enterprise growth and scale efficiently in a regulated market.
There was a need for a strategic partner to establish leadership across compliance functions — from quality documentation to audit readiness, validation governance, supplier oversight, and certification planning.
The Systematic Approach
Driftpin provided fractional executive leadership as VP of Quality, working closely with cross-functional teams to build a right-sized, audit-ready quality management system tailored to the organization’s needs. The engagement focused on implementing scalable frameworks, gaining ISO 27001 certification, and embedding practical compliance practices into everyday operations.
This included documentation strategy, team training, supplier onboarding, security preparedness, and the development of validation tools and processes to support regulated client deployments. Where needed, Driftpin led internal initiatives and also acted as client-facing quality leadership.
Key Activities
- Developed and maintained a full suite of ~45 policies, SOPs, work instructions, and reference documents
- Established and led the company’s Validation Strategy and supported client-facing validation activities
- Directed the ISO 27001 certification process — from planning through successful certification and two re-certifications
- Created processes for user account management, access control, and HR onboarding/offboarding
- Built and implemented CAPA, root cause analysis, change control, security incident response, and business continuity
- Facilitated supplier qualification and third-party oversight processes
- Delivered and tracked training across internal functions and documentation systems
- Completed five internal audits, managed three third-party penetration tests, and prepared for annual surveillance audits
- Authored the company’s initial AI/ML governance strategy to align product development with emerging regulatory expectations
The Transformation
Through this embedded engagement, the company was able to strengthen its operational maturity, increase confidence in its compliance posture, and support enterprise sales with well-documented quality processes. Certification milestones were achieved without disruption, and audit readiness became part of regular business operations. Validation activities are now predictable, scalable, and aligned with industry expectations.
Measurable Outcomes
- ISO 27001 certification: Successfully certified and re-certified on schedule
- Documentation scale-up: From a handful of SOPs to a fully governed QMS with layered document types
- Audit and client readiness: Validation packages, supplier reviews, and client quality questionnaires consistently addressed with confidence
- Security practices: Documented, tested, and externally validated through multiple audits and PEN tests
- Cross-functional integration: Quality and compliance now embedded in engineering, HR, product, and client operations
Strategic Impact
Driftpin’s fractional leadership model allowed the organization to build and maintain a robust compliance program while remaining agile and focused on product growth. With systems now in place, the company continues to scale with a stronger foundation — supporting faster enterprise onboarding, audit preparedness, and client trust in a regulated ecosystem.
This case study demonstrates our approach to embedded quality leadership, operational scaling, and strategic certification support for regulated SaaS vendors.