QA RA Director Consulting Position

About the role

ProPharma is seeking an experienced strategic advisor to help build out and execute the GMP readiness plan for our Biologics client's lean team, enabling their first GMP-ready product to reach customers sooner and more efficiently.

Responsibilities

• Assess draft 3-platform roadmap, gaps, timelines, and risks
• Recommend which platform to lead with
• Build a phased, gated roadmap with a defensible "launch line" for when it can credibly be sold for GMP use
• Guide (and where needed help execute) design controls, design FMEA, and an IQ/OQ/PQ strategy for a combined instrument, consumable, and software system
• (Possible) Hands-on building of DQ/IQ/OQ/PQ documentation
• Review & refine existing Part 11 roadmap
• Advise as needed on Part 11 execution plans
• Provide critical input into decision of offline versus cloud-based analysis
• Guide a lean QMS spanning all four product elements (instruments, HW consumables, biological consumables, software)
• Address the quality manual, SOPs, document control, supplier qualification, COAs, and how to handle batch-to-batch consumable variability and single-source component risk
• Choose eQMS (or direct DIY eQMS)
• (Possible) Hands-on implementation of QMS and its elements (e.g. drafting SOPs, etc)
• Help determine org strategy for scaling Quality & Regulatory function (identify key remaining gaps; map out which hires to make when; internal vs external support)
• (Possible) Customer-facing Quality & Regulatory leader, lending credibility to Quality & Regulatory strategy for customers considering investing in our platform prior to GMP-readiness
• Engage with customers to gather critical VoC inputs to GMP-readiness

Requirements

• 10+ years in quality, regulatory, or GxP leadership within life sciences
• GMP (21 CFR 211), 21 CFR 11, ISO 9001, eQMS implementation
• Has built quality systems from the ground up – ideally for startups
• Understands how drug manufacturers qualify and adopt supplier technologies for GMP workflows
• Led QA for GMP drug manufacturer, has qualified vendor analytical assays
• Vendor-side, taking scientific instruments from R&D into GMP-ready state for pharma/biotech customers
• Uses right-sized approach (i.e. lean where appropriate; careful not to overbuild)
• Experience supporting products that combine instrumentation, software, biological consumables, and hardware consumables