Part Time Quality Consultant

Piper Companies is seeking an experienced, proactive Part-Time Quality Consultant to join our clients team. This role is crucial in ensuring that developing Quality Management System (QMS) meets, and exceeds, the highest regulatory standards (FDA, GMP) as we move our innovative tech closer to commercialization.

This is a flexible, part-time position ideal for a seasoned quality professional looking to apply their expertise in a fast-paced, pioneering CAR-T manufacturing environment. ~20 hours per week.

Key Responsibilities

• QMS Development & Maintenance: Design, implement, and maintain Quality Management System procedures (SOPs) tailored to cell-derived nanoparticle (CDNP) production.
• Regulatory Compliance: Ensure all operations, materials, and documentation comply with FDA Advanced Manufacturing Technology (AMT) standards.
• Audit Preparation & Execution: Act as the lead for internal quality audits and prepare the team for external regulatory inspections.
• Document Control: Review and approve GMP documentation, including batch records, deviations, CAPAs, and change controls.
• Risk Management: Perform risk assessments on manufacturing processes and supply chain to identify and mitigate potential quality issues.
• Consultative Advice: Advise technical operations and R&D teams on quality-by-design principles.

Qualifications

• Education: Bachelor’s or Master’s degree in Biology, Biotechnology, Chemistry, or a related field.
• Experience: Minimum 7-10+ years of experience in Quality Assurance/Quality Control within the biopharmaceutical industry, with a focus on cell therapies or biologics.
• Expertise: Hands-on experience with FDA/EMA regulations, specifically GMP compliance for advanced therapy medicinal products (ATMPs).
• Skills: Strong analytical thinking, attention to detail, and ability to translate complex regulations into practical, streamlined procedures.
• Adaptability: Proven experience in a startup environment or "scaling up" a QMS from early-stage development to clinical trials.