Inspection Readiness Lead

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.

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.

• 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.

• 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.

• 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.

• 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.

• 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…