QA RA Director Consulting Position (GMP)

Location: United States

Company

hirify.global provides consulting solutions across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

• Assess the three-platform GMP roadmap, identify gaps, risks, and timelines, and recommend the platform to lead with.
• Build a phased, gated roadmap defining a defensible launch line for GMP use.
• Guide design controls, design FMEA, and DQ/IQ/OQ/PQ strategy for integrated instruments, software, and consumables.
• Review and refine the 21 CFR Part 11 roadmap, including offline versus cloud-based analysis decisions.
• Guide the lean QMS build-out across instruments, hardware consumables, biological consumables, and software, including document control, supplier qualification, COAs, and eQMS selection.
• Shape the Quality & Regulatory organization strategy and engage customers to gather voice-of-customer input on GMP readiness.

Requirements

• 10+ years of quality, regulatory, or GxP leadership experience in life sciences.
• Experience with GMP, 21 CFR 211, 21 CFR Part 11, ISO 9001, and eQMS implementation.
• Experience building quality systems from the ground up, ideally in startup environments.
• Experience leading QA for a GMP drug manufacturer and qualifying vendor analytical assays.
• Experience taking scientific instruments from R&D into GMP-ready products for pharmaceutical or biotechnology customers.
• Experience supporting products that combine instrumentation, software, biological consumables, and hardware consumables.

Culture & Benefits

• Full-time position with an emphasis on collaborative and entrepreneurial work.
• hirify.global supports remote working company-wide, while new hires within a reasonably short commute of an office are encouraged to work on a hybrid basis as agreed with their manager.
• Commitment to diversity, equity, inclusion, and equal employment opportunity.
• Applications are personally reviewed, with an outcome provided to every applicant.