ProPharma Group

QA RA Director Consulting Position

ProPharma Group • $130K — $160K *
Western Springs, IL 60558In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 10+ years in quality, regulatory, or GxP leadership in life sciences
  • Expertise in GMP (21 CFR 211), 21 CFR 11, and ISO 9001 standards
  • Experience in building quality systems from scratch, preferably in startup environments
  • Knowledge of how drug manufacturers integrate supplier technologies into GMP workflows
  • Previous QA leadership in GMP drug manufacturing with vendor qualification experience
  • Vendor-side experience transitioning scientific instruments from R&D to GMP compliance
  • Ability to apply a lean methodology to quality processes without excessive overbuilding.

Responsibilities

  • Assess and refine the GMP platform roadmap, identifying gaps and risks
  • Recommend the primary platform for market launch
  • Develop a phased roadmap with clear launch milestones for GMP products
  • Guide the execution of design controls and risk management strategies
  • Review and enhance the 21 CFR Part 11 compliance roadmap
  • Advise on execution plans for 21 CFR Part 11
  • Oversee the development of a comprehensive Quality Management System (QMS)
  • Determine the organizational strategy for scaling Quality & Regulatory functions.

Benefits

  • Potential for hands-on involvement in quality system implementation
  • Opportunity to shape key organizational quality strategy
  • Work closely with customers to gather insights for GMP-readiness
  • Collaboration with a lean, dedicated team focused on innovation
  • Engagement with cutting-edge biotechnology for functional assays.
Full Job Description
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.


#LI-JH1#LI-ONSITE

About ProPharma Group

ProPharma Group is a pharmaceutical consulting company that provides regulatory compliance, pharmacovigilance, and medical information services to clients in the healthcare industry. The company was founded in 2001 and is headquartered in Shawnee Mission, Kansas. ProPharma Group offers a range of services, including clinical trial support, quality assurance, and validation services. The company has worked with clients in a variety of industries, including pharmaceuticals, biotechnology, and medical devices.
Learn more about ProPharma Group
Size
500 employees
Industry
Pharmaceuticals & Biotech
Net Income
$5 million
Founded
2001
5 Year Trend
+30%
Revenue
$50 million
* Ladders Estimates

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