QA/RA Director: GMP Readiness & QMS Strategy

propharmagroup; United States; Hybrid; USD 180,000 - 240,000; Full time

Job summary

ProPharma is seeking an experienced Quality & Regulatory leader to guide GMP readiness, Part 11 roadmap, and QMS build-out across instrument, hardware, software, and consumables. You will help scale the quality & regulatory function, engage with customers, and drive lean, risk-based approaches to GMP workflows.

This role requires extensive leadership in life sciences quality systems, regulatory compliance, and vendor management, with a focus on delivering GMP-ready platforms to biotech and

Qualifications

• 10+ years in quality, regulatory, or GxP leadership within life sciences.

Responsibilities

• Assess GMP platform roadmap, gaps, timelines, and risks.
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• Guide design controls, FMEA, and IQ/OQ/PQ strategies.

Skills

GxP leadership

Quality systems design

Regulatory strategy

Lean processes

Cross-functional leadership

Vendor management

Tools

eQMS

Job description

ProPharma is seeking an experienced Quality & Regulatory leader to guide GMP readiness, Part 11 roadmap, and QMS build-out across instrument, hardware, software, and consumables. You will help scale the quality & regulatory function, engage with customers, and drive lean, risk-based approaches to GMP workflows.

This role requires extensive leadership in life sciences quality systems, regulatory compliance, and vendor management, with a focus on delivering GMP-ready platforms to biotech and