Director of Regulatory Inspection Readiness

Celldex Therapeutics, Inc.; Hampton (NJ); On-site; USD 177,000 - 229,000; Full time

Job summary

Celldex Therapeutics, Inc. seeks an experienced Director to lead the inspection management program, ensuring readiness for FDA/ international inspections and partner audits.

You will coordinate across Quality, Manufacturing, Supply Chain, Regulatory Affairs, Clinical Development, and Commercial functions to support a transition to commercial readiness. The role requires a strong background in GMP compliance, regulatory inspections, and CAPA management, with global CMOs experience preferred.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology, or related discipline. Advanced degree is a plus.
• Minimum 10+ years of experience in Quality Assurance, GMP Compliance, Regulatory Inspection Management, or Quality Systems within biotechnology, pharmaceuticals, or biologics manufacturing.
• Demonstrated experience leading FDA and international regulatory inspections.
• Direct experience working with CMOs and global supply networks.
• Experience managing Health Authority responses and CAPA follow ups
• Experience supporting biologics, monoclonal antibodies, sterile products, or advanced therapeutics preferred.
• Experience within both clinical-stage and commercial-stage environments strongly preferred.
• Experience with commercial launch readiness and post-approval quality operations highly desirable.
• Patient Focused
• Strategic Leadership
• Cross-Functional Stake Holder Management
• Balanced Judgement
• Risk Based Decision Making
• Results Driven

Responsibilities

• Creation of an Inspection Management Program for Celldex and our CDMO.
• Creation of a living inspection readiness program to ensure Celldex, and its CDMOs remain inspection ready.
• Work with the Quality CDMO Management team to ensure 'Hot Topics' at our CDMOs are prepared for prior to Health Authority Inspections.
• Establishment of a Health Authority Inspection Management Process for Celldex, and for our CDMOs.
• Responsible for the response process for all Health Authority Inspection.
• Responsible for ensuring CAPAs created by Health Authority Inspections are followed up on and are complete on time 100% of the time.
• Development of metrics to track performance

Skills

Quality Assurance

GMP Compliance

Regulatory Inspections

CAPA Management

CMO Experience

Biologics

Education

Bachelor's degree in Life Sciences/Engineering/Pharmacy

Advanced degree preferred

Job description

Celldex Therapeutics, Inc. seeks an experienced Director to lead the inspection management program, ensuring readiness for FDA/ international inspections and partner audits.

You will coordinate across Quality, Manufacturing, Supply Chain, Regulatory Affairs, Clinical Development, and Commercial functions to support a transition to commercial readiness. The role requires a strong background in GMP compliance, regulatory inspections, and CAPA management, with global CMOs experience preferred.