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TQE FLEX - Scalable Expertise. Sustained Excellence.

  • Rachel Kula (TQE)
  • Nov 12
  • 1 min read

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🔹 TQE Flex → Fractional Quality & Compliance Services


Purpose


Provide scalable, on-demand quality leadership to biotech, pharma, and medical-device organizations that need expert support without hiring full-time staff.


🔹 Core Services

Category

Description

Fractional QA Leadership

Serve as acting Head of Quality / Management Rep / QP on retainer

Inspection & Audit Readiness

Health authority prep, mock audits, CAPA tracking, response strategy

QMS Implementation & Optimization

Gap assessment, SOP authoring, document control alignment

Supplier & Vendor Oversight

Remote and onsite audits, supplier qualification programs

Process Training & Coaching

Practical, role-specific quality mentorship (pairs with Academy)


🔹 Sample Engagement Tiers

Tier

Hours / Month

Example Deliverables

Fee Range

Flex Starter

10–20 hrs

Advisory, doc review, CAPA consult

$3,000 – $5,000

Flex Ops

30–50 hrs

QMS support, internal audit, team training

$7,000 – $10,000

Flex Director

60–80 hrs

Mgmt rep, inspection lead, KPI oversight

$12,000 – $18,000

Flex Enterprise

80–120 hrs

Continuous improvement, multi-site governance

$18,000 – $25,000

(Rates assume $200–$250 / hr blended senior-consultant rate.)

 
 
 
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