About Celldex
Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive—focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.
Overview
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.
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
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
Compensation Statement
The expected base salary for this position is: $176659.00 to $229427.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, 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, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.
