What are the responsibilities and job description for the Inspection Readiness Lead position at Made Scientific?
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. Operating from two U.S.-based manufacturing facilities, 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 all sites and regulatory interactions.
Key Responsibilities
Inspection Readiness & Regulatory Compliance
• Design, implement, and sustain a multi-site 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 across all manufacturing sites.
• 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 across Princeton and Newark sites.
• 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 cross-site 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 across sites.
Quality Systems Interface & Continuous Improvement
• Partner with Quality Systems, Site Quality, and Technical Operations teams to ensure audit-ready performance across all sites.
• Analyze inspection and audit trends to identify systemic compliance risks and drive cross-site 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.