Software Vendor That Needs Senior Quality Leadership but Can't Justify Full-Time
A growing GxP software company that needs VP-level quality expertise without the permanent headcount.
The Situation
You’re a GxP software vendor — maybe 20-80 employees. You’ve built a solid product, but your enterprise customers are asking harder questions about your quality system, validation approach, and compliance posture. You need someone who can build and lead a quality program, interface with customers during audits and qualification, and provide strategic direction — but a full-time VP of Quality doesn’t fit your budget or headcount plan.
What Goes Wrong Without Help
- Quality responsibilities fall to developers or product managers who don’t have the regulatory background
- Customer audits and qualification questionnaires take weeks to respond to — and the responses lack confidence
- Your QMS (if you have one) exists on paper but doesn’t drive actual behavior
- Validation strategy is reactive — you build evidence packages when customers demand them, not proactively
- ISO certification stalls because nobody owns the program end-to-end
What Driftpin Does
- Fractional VP of Quality / Head of QA — ongoing executive leadership at a fraction of full-time cost
- QMS establishment or remediation — build or fix quality systems that work for your size and maturity
- Customer-facing quality leadership — lead audit responses, qualification support, and compliance discussions
- Validation strategy — define your CSV/CSA approach and build repeatable evidence packages
- ISO certification ownership — drive 27001 or 9001 programs from gap assessment through certification
- Team development — build internal quality capability so the role can eventually transition
Typical Engagement
Duration: 6-12 months, typically 2-3 days per week
Outcome: A functioning quality organization with executive leadership, a QMS that reflects how your company actually works, and the ability to confidently engage with enterprise customers on compliance.