Welcome to BB Quality Solutions

Director-level QA leadership on a scoped hourly commitment. For companies that need senior quality expertise before a full-time head of quality is the right hire.

What it covers:

• Quality function strategy and roadmap
• eQMS oversight and governance
• Deviation, CAPA, and change control program leadership
• Client-facing quality liaison and audit response
• Vendor and supplier quality management
• Team building, training program design, and staff mentorship
• Executive reporting and board-level quality metrics

Pricing:

• 20 hours/week retainer: $6,500/month
• 30 hours/week retainer: $9,500/month
• Custom hour commitments available for scoped needs
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Minimum term: 3 months. Month-to-month thereafter.

Best fit: Series A/B/C biotechs, small-to-mid CDMOs (under 300 employees), specialty pharma operations preparing for scale.

Scoped, deliverable-based work with fixed pricing and defined outcomes. When you know what you need built and want a senior operator to build it.

eQMS Foundation Build — $22,000 / 90 days
Greenfield or replatform configuration of MasterControl, ZenQMS, or comparable eQMS. Includes URS authorship, module architecture (deviations, CAPAs, change controls, batch records, risk, audit), workflow design, controlled document setup, user role configuration, training rollout, and validation documentation aligned to risk-based CSV / GAMP 5 principles. Delivered ready for production use.

Inspection Readiness Sprint — $15,000 / 60 days
Focused pre-inspection engagement for FDA, EMA, or client audits. Includes gap assessment, mock inspection facilitation, remediation planning, document readiness review, personnel prep sessions, and on-site inspection support during the actual visit (travel expenses additional).

Quality System Architecture Review — $8,500 / 30 days
Structured assessment of an existing quality system with prioritized recommendations. Includes review of governing procedures, document control practices, deviation and CAPA metrics, training program design, and risk framework. Delivered as a written report with 90-day implementation roadmap.

Quality Agreement Development — $4,500 per agreement
End-to-end drafting or review of Quality Agreements between contracting parties (biotech-CDMO, sponsor-vendor, and similar). Includes template harmonization for organizations managing multiple client or vendor relationships.

Custom Scoped Projects — pricing on inquiry
For work that doesn't fit the packages above but has a defined outcome, I scope and price to the specific engagement.

Hourly senior-quality perspective for biotech founders and small-CDMO leadership. For the strategic conversations where you don't need a project — you need a trusted perspective.

How it works:

• Rate: $200/hour
• Minimum retainer: 5 hours ($1,000)
• Session structure: 60- or 90-minute working conversations, scheduled as needed
• Common topics: Quality strategy ahead of funding events, regulatory milestone planning, quality function build-vs-hire decisions, inspection preparation strategy, executive-level quality metrics and reporting to boards

Best fit: Founders and executives who need a senior QA sounding board without ongoing engagement commitment.