Inspection Readiness Lead

About Made Scientific Made Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors. Position Summary The Inspection Readiness Lead (Associate Director) is a quality leader responsible for establishing, maintaining, and continuously improving a state of inspection readiness across GMP cell therapy operations, spanning clinical through commercial stages. Reporting to the VP of Quality and Compliance, this individual partners closely with the Site Quality & GMP Compliance Lead and key cross-functional stakeholders to ensure GMP alignment, consistent execution, and inspection readiness across regulatory interactions. Key Responsibilities Inspection Readiness & Regulatory Compliance • Design, implement, and sustain an inspection readiness program supporting clinical and commercial cell therapy manufacturing. • Maintain a continuous state of readiness for FDA, EMA, and other global health authority inspections, as well as client audits. • Ensure alignment with applicable regulations, including 21 CFR Parts 210/211, 1271, EU GMP (Annex 1 & 2), ICH guidelines, and global regulatory expectations for advanced therapies. • Collaborate with Regulatory Affairs and the PMO to translate evolving regulatory and client expectations into actionable inspection readiness strategies, standards, and best practices. Regulatory Inspections, Client Audits & Customer Assessments • Serve as the front-room inspection lead for regulatory authority inspections and client audits. • Lead and coordinate inspection and audit readiness activities, including mock inspections, readiness assessments, gap analyses, and SME coaching. • Coordinate execution of inspections and audits, including inspection teams, war room operations, daily briefings, issue tracking, and executive updates. • Lead the development and execution of inspection and audit responses, including FDA 483 observations, regulatory commitments, and client responses, ensuring consistency. Quality Systems Interface & Continuous Improvement • Partner with Quality Systems, Site Quality, and Technical Operations teams to ensure audit-ready performance. • Analyze inspection and audit trends to identify systemic compliance risks and drive remediation and continuous improvement. • Support inspection readiness for new site start-ups, facility expansions, technology transfers, and commercial launches. Leadership, Influence & Collaboration • Provide functional leadership and mentoring on inspection readiness to SMEs and site quality partners, fostering a culture of proactive compliance and inspection confidence. • Align and influence stakeholders across Quality, Technical Operations, MSAT, Regulatory Affairs, and Program Management to drive inspection readiness initiatives. • Serve as a trusted advisor to senior leadership on inspection risk, regulatory exposure, and readiness status. • Champion a strong culture of quality and compliance, reinforcing consistent behaviors, decision-making, and regulatory interactions during audits and inspections. Required Qualifications • Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field. • 10+ years of progressive quality leadership experience in cell therapy, biotech, or biologics, with deep exposure to GMP operations. • Strong expertise in cell therapy or ATMP manufacturing and in-depth knowledge of global GMP regulations (FDA, EMA, ICH, ROW). • Proven track record in a CDMO environment managing multiple client programs and regulatory compliance requirements. • Demonstrated leadership during regulatory inspections, including FDA inspections and 483 resolution. • Excellent verbal and written communication skills, with the ability to articulate complex compliance topics to inspectors, clients, and executive leadership. • Experience leading audit and inspection planning, execution, and response activities. • Willingness to work flexible hours, including evenings, weekends, and shift-based schedules as needed. • Strong organizational skills with the ability to prioritize and manage multiple demands while maintaining a solution-oriented mindset. Preferred Qualifications • Experience supporting multiple clients simultaneously within a CDMO. • Direct experience with pre-approval inspections (PAIs), BLA/MAA readiness, or commercial launch inspections. • Experience supporting rapid-growth organizations, new site start-ups, or late-stage to commercial transitions. • Lean, Six Sigma, or quality excellence certifications. Educational Requirement • B.S. in Life Sciences, Engineering, or related discipline required; advanced degree preferred. Physical Requirements • Ability to perform essential job functions in compliance with company standards, including productivity and attendance. • Willingness to work in various controlled environments, including CNC/ISO7–8 cleanrooms. • Ability to lift up to 25 lbs and perform physical tasks such as bending, standing, and working with cell-based products or chemicals. • Must be flexible and adaptable to changing priorities and dynamic environments.

Created: 2026-03-11