Made Scientific · 2 days ago
Inspection Readiness Lead
Princeton, NJ
Full-time
Onsite
Director/Executive
10+ years expMade Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization specializing in cell therapy products. The Inspection Readiness Lead is responsible for establishing and maintaining inspection readiness across GMP cell therapy operations while collaborating with key stakeholders to ensure compliance and readiness for regulatory interactions.
BiotechnologyGeneticsManufacturing
Hiring Manager
Sia Madan
Responsibilities
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
Qualification
Required
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
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
Company
Made Scientific
Made Scientific is a leading US-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.
51-200 employees
H1B Sponsorship
Made Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
Funding
Current Stage
Growth StageTotal Funding
$29.2MKey Investors
National Institute for Innovation in Manufacturing Biopharmaceuticals
2024-01-03Series A· $29.2M
2023-06-27Grant
2022-04-19Acquired
Leadership Team
Syed T. Husain
Chairman and Chief Executive Officer
David Smith
Vice President of Development
Recent News
Precedence Research
2025-11-14
GlobeNewswire News Room
2025-03-06
Company data provided by crunchbase