Director, Quality Inspection Management

Scorpion Therapeutics; Hampton (NJ); On-site; USD 140,000 - 190,000; Full time

Job summary

Celldex is seeking a Lead Inspection Management and Regulatory Compliance professional to guide readiness for FDA, EMA, MHRA, Health Canada inspections, partner audits, and launch activities as it transitions to a commercial-stage biotech.

The role requires overseeing inspection responses, CAPA follow-ups, and developing metrics to track performance across Quality, Manufacturing, Regulatory, Clinical, and Commercial areas.

Qualifications

• Bachelor's degree in a life sciences, pharmacy, engineering, chemistry, microbiology, or related field.
• 10+ years in GMP quality assurance, regulatory inspection management, or related biotech/pharma roles.
• Proven experience leading FDA and international inspections.

Responsibilities

• Develop and sustain inspection readiness programs across Quality, Manufacturing, Supply Chain, Regulatory, Clinical, and Commercial functions; oversee inspection responses and CAPA follow-ups.
• Establish metrics for performance tracking.
• Collaborate with CDMOs to prepare for inspections and address 'Hot Topics.'

Skills

GMP QA

Inspection Management

Regulatory Audits

Education

Bachelor's degree in Life Sciences/Pharmacy/Engineering/Chemistry/Microbiology

Job description

Role:

Lead inspection management and regulatory compliance for Celldex as it transitions to a commercial-stage biotech, ensuring readiness for FDA, EMA, MHRA, Health Canada inspections, partner audits, and launch activities.

Responsibilities:

Responsibilities: develop and sustain inspection readiness programs across Quality, Manufacturing, Supply Chain, Regulatory, Clinical, and Commercial functions; oversee inspection responses and CAPA follow-ups; establish metrics for performance tracking; collaborate with CDMOs to prepare for inspections and address 'Hot Topics.'

Qualifications:

Qualifications: Bachelor's in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology, or related; 10+ years in GMP Quality Assurance, Regulatory Inspection Management, or related fields within biotech/pharma; proven experience leading FDA and international inspections; experience with biologics, monoclonal antibodies, sterile products, or advanced therapeutics; familiarity with clinical and commercial stages, supply networks, and post-approval operations.

HighValue:

HighValue: biologics, monoclonal antibodies, sterile products; biologics development; GMP compliance; global regulatory inspections; clinical to commercial transition.

WorkSetup:

WorkSetup: Not specified; focus on cross-functional and global coordination.