For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Our Biologics client builds instruments, software, hardware consumables, and biological consumables for functional cell-based assays. They have a lean team in need of an experienced strategic advisor to help build out and execute their GMP readiness plan so their first GMP-ready product can reach customers sooner and more efficiently

GMP Platform roadmap

• Assess our 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) hand-on building of DQ/IQ/OQ/PQ documentation

21 CFR Part 11 roadmap

• Review & refine our existing Part 11 roadmap
• Advise as needed on Part 11 execution plans
• Provide critical input into decision of offline versus cloud-based analysis

QMS Build-out – Instruments, HW Consumables, Biological Consumables, Software

• Guide a lean QMS spanning all four product elements
• 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)

Organizational Quality Strategy

• 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.

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