Quality Assurance Manager

Location: Hampton

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

The Manager, Quality Assurance role will support manufacturing operations, late‑stage clinical development, and commercial readiness. This role plays a critical part in ensuring compliance with FDA regulations, cGMPs, and internal Quality Systems while supporting Phase 3 clinical trials for CDX‑0159, preparation and submission of the Biologics License Application (BLA), and subsequent commercial activities.

The ideal candidate brings strong regulatory judgment, hands‑on QA expertise, and a proactive leadership mindset focused on inspection readiness, compliance excellence, and continuous improvement.

Responsibilities

Quality Leadership & Compliance

* Provide Quality Assurance leadership for manufacturing operations in compliance with FDA regulations, ICH guidelines, and cGMP requirements.

* Ensure consistent implementation and adherence to the company Quality Management System (QMS).

* Serve as a quality decision‑maker, applying risk‑based thinking and sound regulatory judgment.

Document Review & Oversight

* Review, approve, and audit complex quality documentation, including:

* Master Batch Records (MBRs)

* Executed Batch Records (EBRs)

* CMO deviations, investigations, and complaints

* QC analytical methods, stability protocols, and associated data

* Ensure documentation meets regulatory expectations for accuracy, completeness, traceability, and data integrity.

Clinical, Regulatory & Commercial Support

* Provide QA support for Phase 3 clinical activities for CDX‑0159, ensuring compliance with applicable GxP requirements.

* Support the review, authoring, and submission of quality components of the BLA.

* Partner cross‑functionally to support commercial readiness, including process validation, product disposition, and lifecycle management.

CMO & Vendor Oversight

* Provide QA oversight of Contract Manufacturing Organizations (CMOs) and critical vendors.

* Support vendor qualification, audits, and ongoing performance monitoring.

* Lead or support responses to audit observations, including CAPA development and follow‑up.

Audits

* Participate in and support vendor audits, and internal audits.

* Lead preparation, hosting, and response activities, including regulatory commitments and remediation efforts.

SOPs & Continuous Improvement

* Review, approve, and contribute to the development and maintenance of Standard Operating Procedures (SOPs).

* Identify opportunities to improve quality systems, processes, and compliance maturity.

* Promote a culture of quality, accountability, and continuous improvement across the organization.

Leadership & Collaboration

* Collaborate effectively with Manufacturing, QC, Regulatory Affairs, Clinical, Supply Chain, and external partners.

* Communicate quality risks and compliance status clearly to senior management.

Qualifications

* Bachelor's degree in Life Sciences, Engineering, or related field required. Advanced degree (MS, PhD) preferred

* Minimum of 8-10 years of progressive Quality Assurance experience in the biopharmaceutical or biotechnology industry.

* Demonstrated experience supporting manufacturing operations under cGMP.

* Hands‑on experience with batch record review, deviations, investigations, CAPAs, and CMO oversight.

* Direct experience supporting late‑stage clinical programs and BLA submissions strongly preferred.

* Deep knowledge of FDA regulations, cGMPs, ICH guidelines, and Quality Systems.

* Strong leadership, decision‑making, and problem‑solving…