GMP-Ready QA/RA Director — Quality & Regulatory Strategy

ProPharma; Raleigh (NC); Hybrid; USD 130,000 - 180,000; Full time

Job summary

ProPharma in Raleigh seeks an experienced leader in quality, regulatory, and GxP to guide GMP readiness for a biotech/pharma ecosystem, including instrument, software, and consumables. Lead QMS development, Part 11 adherence, vendor qualification, and cross-functional execution with a lean, scalable approach.

The role requires 10+ years in life sciences quality/regulatory, and a proven track record building quality systems from the ground up to support GMP projects and customer partnerships.

Qualifications

• 10+ years in quality, regulatory, or GxP leadership within life sciences.
• GMP (21 CFR 211), 21 CFR 11, ISO 9001, eQMS implementation.
• Built quality systems from the ground up for startups.
• Understands supplier technologies for GMP workflows.
• Led QA for GMP drug manufacturers and qualified vendor analytical assays.
• Vendor-side experience taking instruments from R&D to GMP-ready state.
• Uses a lean, right-sized approach; avoids overbuild.
• Experience with instrumentation, software, biological consumables, and hardware consumables.

Responsibilities

• Assess draft GMP platform roadmap, gaps, timelines, and risks.
• Recommend which platform to lead with and build a phased roadmap.
• Guide IQ/OQ/PQ documentation and design controls for integrated systems.
• Support QMS build-out across instruments, HW consumables, biological consumables, and software.
• Shape Organizational Quality Strategy and hiring plan for scaling function.

Skills

Quality leadership

Regulatory strategy

GxP compliance

Vendor qualification

Lean approach

IQ/OQ/PQ guidance

eQMS implementation

Cross-functional collaboration

Tools

GMP frameworks

Job description

ProPharma in Raleigh seeks an experienced leader in quality, regulatory, and GxP to guide GMP readiness for a biotech/pharma ecosystem, including instrument, software, and consumables. Lead QMS development, Part 11 adherence, vendor qualification, and cross-functional execution with a lean, scalable approach.

The role requires 10+ years in life sciences quality/regulatory, and a proven track record building quality systems from the ground up to support GMP projects and customer partnerships.