Location: Remote (U.S. based)
Department: Quality & Regulatory
Reports to: Chief Executive Officer
Employment Type: Full-Time

🚀 About Imbiome Inc.

Imbiome Inc. is a pioneering biotechnology company on a mission to redefine human and animal health through pharmabiotics—advanced bacterial products made from live bacteria. Emerging from stealth mode in 2025, we’re building a platform that optimizes the functional state and targeted delivery of microorganisms to treat microbiome-linked diseases of the modern age.

Headquartered in Albany, NY, and partnered with the Borisenok Family Foundation Upstream Lab at the Albany College of Pharmacy & Health Sciences, we combine deep scientific rigor with entrepreneurial energy. Our science-first, purpose-driven culture is rooted in innovation, impact, and integrity.

🎯 About the Role

We’re seeking a strategic, hands-on Director of Quality to build and lead Imbiome’s quality systems from the ground up. This is a rare opportunity to help define the quality and regulatory foundation of a breakthrough biotech company at a critical inflection point.

You’ll work closely with leadership, scientific teams, and external partners to establish and scale robust quality systems that support research, development, clinical, and ultimately commercial activities in both human and animal health.

🎯 Goals & Objectives

• Design and implement Imbiome’s Quality Management System (QMS) in alignment with regulatory standards (FDA, EMA, ICH, ISO)
• Lead quality strategy across the product lifecycle, including preclinical, clinical, and manufacturing phases
• Oversee GxP compliance (GLP, GMP, GCP as applicable) across internal teams and CRO/CMO partners
• Develop and manage QA processes for documentation control, audits, CAPA, risk management, and training
• Serve as the primary quality interface with regulatory authorities and participate in inspections and filings
• Partner cross-functionally to embed quality in R&D workflows, tech transfer, and commercial readiness
• Build and grow the Quality function as the company scales

🧠 What You’ll Do

• Collaborate with leadership to align quality strategy with broader product and go-to-market objectives.
• Foster a proactive quality culture across Imbiome, promoting continuous improvement, training, and cross-functional accountability.
• Recruit and develop a small, high-performing quality team to scale quality oversight with company growth.
• Qualify and monitor external partners (e.g., manufacturers, ingredient suppliers, testing labs) with a focus on product quality, traceability, and compliance.
• Ensure readiness for regulatory audits and market entry through robust documentation, batch recordkeeping, and GMP-aligned operations.
• Support the development and launch of safe, effective, and compliant dietary supplement products by embedding quality practices in R&D, sourcing, and production workflows.
• Establish a foundational Quality Management System (QMS) tailored to Imbiome’s stage and product pipeline, ensuring compliance with applicable supplement and nutraceutical quality standards (e.g., FDA 21 CFR Part 111).

💡 What We’re Looking For

• Bachelor’s or advanced degree in life sciences, quality, or a related field
• 10+ years of quality leadership in biotech, pharmaceuticals, or related regulated industry
• Deep understanding of GxP guidelines, quality systems, and regulatory frameworks
• Experience supporting IND-enabling activities and/or commercial product launch
• Strong communication, problem-solving, and organizational skills
• Comfortable working independently in a fast-paced, startup environment

🌱 Bonus Points

• Experience with microbiome, live biotherapeutic products (LBPs), or biologics
• Familiarity with veterinary or dual-use (human/animal) product pathways
• Prior experience building a QMS from scratch in an early-stage company
• Enthusiasm for mission-driven science and collaborative innovation

💼 What We Offer

• Competitive compensation package with equity
• Health and other insurance
• Flexible work hours and remote-first culture
• A role with high visibility and company-wide impact
• Opportunity to shape the future of a category-defining biotech company

🤝 How to Apply

Ready to join us in building the next frontier in microbiome science? Please send your resume and a brief note about your interest in the role to careers@imbiome.com. We value every application and will be in touch with candidates whose background matches our needs.