QA RA Director Consulting Position

ProPharma Group•Raleigh, NC

9d•Hybrid

About The Position

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.

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.

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) hand-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
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