Director, Quality Inspection Management
About The Position
This role will serve as the primary architect and leader of Celldex's inspection management program, ensuring continued state of readiness for regulatory authority inspections, partner audits, and commercial launch activities. The Director will collaborate across Quality, Manufacturing, Supply Chain, Technical Operations, Regulatory Affairs, Clinical Development, and Commercial functions to establish and maintain a sustainable inspection readiness framework. The successful candidate will play a key role in supporting Celldex's transition from a clinical-stage organization to a commercial biotechnology company while ensuring compliance with FDA, EMA, MHRA, Health Canada, ICH, and other global regulatory requirements. This individual will provide leadership for GMP compliance initiatives, inspection preparation, audit response management, quality risk mitigation, and continuous improvement activities throughout the product lifecycle.
Requirements
- Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology, or related discipline.
- 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
Nice To Haves
- Advanced degree is a plus.
- 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.
Responsibilities
- Creation of an Inspection Management Program for Celldex and our Contract Development and Manufacturing Organizations (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
Benefits
- annual discretionary bonus
- long term incentive
- 401(K) plan with employer contribution
- health care and other insurance benefits (for employee and family)
- paid holidays
- vacation
- sick days
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What This Job Offers
Job Type
Full-time
Career Level
Director
