Position: Temporary Consultant
Location: Remote
Industry: Medical Device/Pharmaceuticals
Duration: Project-based, with potential for extension

Company Overview:
We are an early-stage company developing a pre-clinical drug-device combination product focused on the gastrointestinal (GI) space. As we move toward advancing our product pipeline, we are seeking a highly experienced consultant to help build out our Quality Management System (QMS) in alignment with FDA guidance, ISO 13485, and GMP standards. The consultant will guide our leadership team to ensure compliance while maintaining a lean system, optimized for working with contract manufacturing partners.

Key Responsibilities:

• QMS Development: Design and implement a QMS from scratch, tailored to our unique needs as a pre-clinical company. Ensure it adheres to relevant FDA, ISO 13485, and GMP regulations.
• FDA/ISO13485/GMP Compliance: Provide expert guidance on the interpretation and implementation of FDA guidance, ISO 13485, and GMP requirements for a drug-device combination product.
• Leadership Guidance: Collaborate with senior leadership to ensure the QMS is both effective and lean, focusing on processes and procedures that can be easily maintained given that most core development and manufacturing will occur with contract partners.
• System Scalability: Ensure the QMS is adaptable to scale with future clinical development, regulatory filings, and eventual commercialization.
• Documentation & Training: Help build essential QMS documentation, SOPs, and training materials for in-house staff and external partners, ensuring that the system is easy to manage and audit.

• Proven experience in full-scale implementation of QMS systems for drug-device combination products, ideally in the early-stage or pre-clinical setting.
• Strong knowledge of FDA regulations, ISO 13485, and GMP standards.
• Experience working with contract manufacturing organizations (CMOs) and outsourcing development/production activities.
• Previous experience with lean QMS strategies, particularly in early-stage companies where efficiency and cost-effectiveness are paramount.
• Ability to work independently, communicate effectively with leadership, and provide practical solutions to regulatory challenges.
• Strong documentation, training, and mentoring skills to build a system that is both functional and maintainable.

About Steel Therapeutics

Steel Therapeutics is an Iowa-based pharmaceutical company focused on increasing access to life-changing therapies that have a track record of efficacy in compounding pharmacies. With a team of founders that have been active in building both retail compounding programs and cutting-edge medical devices, Steel’s work lives at the intersection of high impact drug candidates and innovative delivery systems.

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